Devices, systems, and methods to control stomach volume

ABSTRACT

Embodiments disclosed herein relate to methods, devices, and computer systems thereof for reducing stomach volume in a subject. In certain embodiments, a subject receives a stomach-volume-reducing device that optionally includes at least one reservoir configured to release at least one appetite suppressant. In an embodiment, the stomach-volume-reducing device is responsive to one or more environmental conditions of the subject, for example, pH or chemical chemicals in the stomach of the subject. In an embodiment, the stomach-volume-reducing device controls hunger in the subject.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is related to and claims the benefit of theearliest available effective filing date(s) from the following listedapplication(s) (the “Related Applications”) (e.g., claims earliestavailable priority dates for other than provisional patent applicationsor claims benefits under 35 USC §119(e) for provisional patentapplications, for any and all parent, grandparent, great-grandparent,etc. applications of the Related Application(s)). All subject matter ofthe Related Applications and of any and all parent, grandparent,great-grandparent, etc. applications of the Related Applications,including any priority claims, is incorporated herein by reference tothe extent such subject matter is not inconsistent herewith.

RELATED APPLICATIONS

-   -   For purposes of the USPTO extra-statutory requirements, the        present application constitutes a continuation-in-part of U.S.        patent application Ser. No. 13/385,574, entitled DEVICES,        SYSTEMS, AND METHODS TO CONTROL STOMACH VOLUME, naming        Roderick A. Hyde, Michael A. Smith, Elizabeth A. Sweeney,        Lowell L. Wood, Jr., and Richard N. Zare as inventors, filed 24        Feb. 2012, which is currently co-pending, or is an application        of which a currently co-pending application is entitled to the        benefit of the filing date.    -   For purposes of the USPTO extra-statutory requirements, the        present application constitutes a continuation-in-part of U.S.        patent application Ser. No. 13/385,572, entitled DEVICES,        SYSTEMS, AND METHODS TO CONTROL STOMACH VOLUME, naming        Roderick A. Hyde, Michael A. Smith, Elizabeth A. Sweeney,        Lowell L. Wood, Jr., and Richard N. Zare as inventors, filed 24        Feb. 2012, which is currently co-pending, or is an application        of which a currently co-pending application is entitled to the        benefit of the filing date.

The United States Patent Office (USPTO) has published a notice to theeffect that the USPTO's computer programs require that patent applicantsreference both a serial number and indicate whether an application is acontinuation, continuation-in-part, or divisional of a parentapplication. Stephen G. Kunin, Benefit of Prior-Filed Application, USPTOOfficial Gazette Mar. 18, 2003. The present Applicant Entity(hereinafter “Applicant”) has provided above a specific reference to theapplication(s) from which priority is being claimed as recited bystatute. Applicant understands that the statute is unambiguous in itsspecific reference language and does not require either a serial numberor any characterization, such as “continuation” or“continuation-in-part,” for claiming priority to U.S. patentapplications. Notwithstanding the foregoing, Applicant understands thatthe USPTO's computer programs have certain data entry requirements, andhence Applicant has provided designation(s) of a relationship betweenthe present application and its parent application(s) as set forthabove, but expressly points out that such designation(s) are not to beconstrued in any way as any type of commentary and/or admission as towhether or not the present application contains any new matter inaddition to the matter of its parent application(s).

SUMMARY

Various embodiments are disclosed herein that relate to methods,devices, systems, and computer program products for controlling stomachvolume of a subject.

In an embodiment, the stomach-volume-reducing device includes areversibly responsive housing encasing or including at least oneintelligent responsive matrix. In an embodiment, the device issurgically implanted. In an embodiment, the device is held primarily inthe stomach of a subject by its expanded size. In an embodiment, asystem includes circuitry for operating the stomach-volume-reducingdevice.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates a partial view of a particular embodiment of a deviceand system described herein.

FIG. 2 illustrates a partial view of a particular embodiment of a deviceand system with a polymer envelope described herein.

FIG. 3 illustrates a partial view of a particular embodiment of a devicelocated within a subject's body as described herein.

FIG. 4 illustrates a partial view of a particular embodiment of a systemdescribed herein.

FIG. 5 illustrates a partial view of a particular embodiment of a systemand method described herein.

FIG. 6 illustrates a partial view of a particular embodiment of a systemand method described herein.

FIG. 7 illustrates a partial view of a particular embodiment of a systemand method with various motors as described herein.

FIG. 8 illustrates a partial view of a particular embodiment of a systemas described herein.

FIG. 9 illustrates a partial view of a particular embodiment of a systemwith one or more hunger control delivery units as described herein.

FIG. 10 illustrates a partial view of a particular embodiment of asystem as described herein.

FIG. 11 illustrates a partial view of a particular embodiment includingan energy storage device operably coupled to at least one motor asdescribed herein.

FIG. 12 illustrates a partial view of a particular embodiment includingan appetite suppressant reservoir as described herein.

FIG. 13 illustrates a partial view of a particular embodiment of asystem described herein.

FIG. 14 illustrates a partial view of a particular embodiment of asystem including one or more ports as described herein.

FIG. 15 illustrates a partial view of a particular embodiment of asystem described herein.

FIG. 16 illustrates a partial view of a particular embodiment of asystem described herein.

FIG. 17A illustrates a partial view of a particular embodiment of ahunger control delivery reservoir as described herein.

FIG. 17B illustrates a partial view of a particular embodiment of ahunger control delivery reservoir as described herein.

FIG. 18A illustrates a partial view of a particular embodiment of ahunger control delivery reservoir as described herein.

FIG. 18B illustrates a partial view of a particular embodiment of ahunger control delivery reservoir as described herein.

FIG. 19A illustrates a partial view of a particular embodiment of ahunger control delivery reservoir as described herein.

FIG. 19B illustrates a partial view of a particular embodiment of ahunger control delivery reservoir as described herein.

FIG. 20A illustrates a partial view of a particular embodiment of ahunger control delivery reservoir as described herein.

FIG. 20B illustrates a partial view of a particular embodiment of ahunger control delivery reservoir as described herein.

FIG. 21A illustrates a partial view of a particular embodiment of ahunger control delivery reservoir as described herein.

FIG. 21B illustrates a partial view of a particular embodiment of ahunger control delivery reservoir as described herein.

FIG. 22A illustrates a partial view of a particular embodiment of asensor as described herein.

FIG. 22B illustrates a partial view of a particular embodiment of asensor as described herein.

FIG. 22C illustrates a partial view of a particular embodiment of asensor as described herein.

FIG. 23A illustrates a partial view of a particular embodiment of asensor as described herein.

FIG. 23B illustrates a partial view of a particular embodiment of asensor as described herein.

FIG. 23C illustrates a partial view of a particular embodiment of asensor as described herein.

FIG. 24 illustrates a partial view of a particular embodiment of asystem including circuitry as described herein.

FIG. 25 illustrates a partial view of a particular embodiment of adevice including an intelligent responsive matrix as described herein.

FIG. 26 illustrates a partial view of a particular embodiment of asystem including circuitry as described herein.

FIG. 27 illustrates a partial view of a particular embodiment of asystem including circuitry as described herein.

FIG. 28 illustrates a partial view of a particular embodiment of asystem as described herein.

FIG. 29 illustrates a partial view of a particular embodiment of asystem as described herein.

FIG. 30 illustrates a partial view of a particular embodiment of asystem as described herein.

FIG. 31 illustrates a partial view of a particular embodiment of asystem as described herein.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented here.

In an embodiment, at least one of the methods, devices, or computersystems disclosed herein are utilized for controlling stomach volume ina subject. In an embodiment, the methods, devices, or computer systemsdisclosed herein assist in controlling hunger of a subject. In anembodiment, the hunger control is cyclical such that it mimics thesubject's natural hunger cycles. In an embodiment, the methods, devices,or computer systems disclosed herein assist in weight loss in a subjectby reducing the subject's gastric volume and/or suppressing thesubject's appetite.

For example, in an empty state, the stomach is contracted and its mucosaand submucosa are gathered into distinct folds; when distended withfood, the folds are flat, altering the size from approximately 50 mL toapproximately 1 L. The empty stomach is nonmotile and not producing muchacid, although the migrating motor complex is active on a low level.Once a subject becomes aware of food (e.g., by way of smell, thought,sight, etc.), nervous and chemical signals initiate secretion of smallamounts of acid and a low level of gastric motility occurs. As foodenters the stomach, stretching and irritation of the stomach occurs, andthe pH of the stomach is lowered significantly, when secretion ofenzymes ensues and contractions begin. The content of food can affectthe emptying rate (e.g., presence of fat slows rate of stomachemptying). As pH drops and stomach content shifts, acid production isreduced to basal or negative levels. Thus, in an embodiment, the earlierthe device expands to decrease stomach spatial volume in a subject, thebetter hunger will be suppressed. In an embodiment, the stomach-volumereducing device increases the subject's feeling of satiety or reduceshunger. In an embodiment, chemical appetite suppressants are alsoutilized to control hunger. (See, for example, on the worldwide web,arbl.cvmbs.colostate.edu/hbooks/pathphys/digestion/stomach/index.html,the contents of which are incorporated herein by reference.)

In an embodiment, a subject includes, but is not limited to, a human ornon-human animal (for example, pet, livestock, food animals, wildanimals, game animals, etc.).

Stomach Volume Reducing Device

In an embodiment, the stomach volume reducing device includes at leastone of an intelligent responsive gel (e.g., swells), gastric attachment,at least one moveable member, or at least one umbrella type mechanism.For example, in an embodiment, the stomach volume reducing deviceincludes a reversibly responsive expandable device, the reversiblyresponsive expandable device encasing at least one intelligentresponsive matrix that is responsive to at least one chemical in thestomach of a subject. In an embodiment, the device includes at least oneport. In an embodiment, the device includes at least one controllablemicropump or controllable valve operably connected to at least one port.In an embodiment, the device further includes at least one housing. SeeFigure Descriptions for more details.

In an embodiment, the intelligent responsive matrix includes acrystalline colloidal array. Crystalline colloidal arrays are generallysynthesized through a free-radical heterogeneous nucleation emulsionpolymerization. See, for example, the worldwide web at:pitt.edu/˜asher/homepage/colgrp.html, visited on Jan. 6, 2012, thecontent of which is incorporated herein by reference. Crystallinecolloidal arrays can be prepared in the form of particles that areapproximately 100-400 nm in diameter. The reactants for thepolymerization include an emulsifier, slightly water-soluble monomers, aless water-soluble crosslinker, a water-soluble initiator, and a bufferin an aqueous polymerization medium. The surface charge and size of theresulting particles can be altered by varying the relative amounts ofthese reactants. Id. For example, a typical colloidal particle synthesisby emulsion polymerization (for approximately 100 nm particles) includesapproximately 137.5 mL water, 60.0 mL styrene, 2.33 g divinylbenzene,2.87 g COPS-1, 2.0 g MA-80, 0.17 g NaHCO₃, 0.75 g N₂H₈S₂O₈, heated at70° C. for 3 hours. Aqueous suspensions of monodisperse, highly-chargedpolystyrene particles self-assemble into highly-orderedthree-dimensional arrays, known as crystalline colloidal arrays (CCAs).Id. Likewise, a CCA lattice can be stabilized by polymerizing it withina hydrogel to form a polymerized crystalline colloidal array (PCCA) withnonionic polymerizable monomers, cross-linkers and photoinitiators. Whenmolecular recognition groups are incorporated into the hydrogel backboneeither during or after polymerization, the resulting intelligentpolymerized crystalline colloidal array (IPCCA) will optically report onthe concentration of the analyte of interest. As the analyte of interestis bound, there will be a change in the free energy of the system,resulting in a change in the equilibrium volume of the hydrogel and achange in the observed diffraction from the PCCA.

Consequently, many CCAs are formed into sensors, for example, a photoniccrystal glucose sensor, protein marker sensors, organophosphate sensors,ammonia sensors, zinc sulfide particle sensor, or others. Id.

In an embodiment, the stomach volume reducing device includes at leastone sensor. In an embodiment, the stomach volume reducing deviceincludes at least one transmitter.

FIG. 1 illustrates an embodiment in which a reversibly responsiveexpandable housing device 100 is a polymer envelope 101 that is encasingglucose-responsive, pH-sensitive hydrogel particles. A portion of thehydrogel particles or a subset of the ingested envelopes may include,within the glucose-responsive, pH-sensitive hydrogel 103, an appetitesuppressant 105 that is released upon the gel swelling in response tothe glucose and in the presence of low pH. Further, the device includesa microchip 106, piezoelectric pump 104, a port 144 that may be operablyassociated with a sensor 108 for sensing at least one environmentalcondition 172 of the subject's stomach, and one or more microvalves 109.

FIG. 2 illustrates a reversibly responsive expandable device housing 200that is, in this embodiment, a non-toxic polymer envelope 210 encasingan actuatable mechanical member 220 (truss rod, as noted otheractuatable mechanical members can be used). As illustrated in FIG. 2,the actuatable mechanical members are moveable by at least onepiezoelectric motor 230. In addition, the device 200 includes a motorcontrol chip 250 (operably coupled to control circuitry) and anellipsoid space filler 270. In an embodiment, a sensor 260 is operablycoupled to at least one of the actuatable mechanical member, or themotor.

FIG. 3 illustrates a stomach volume reducing device in a collapsed state(FIG. 3A), as well as in an expanded state (FIG. 3B). For example, thechemical is ingested prior to an expected meal, and thechemical-detecting sensor, after detecting the chemical, transmits anelectrical signal to the umbrella-like devices to actuate thepiezo-electric motors, erect the ellipsoid space fillers, and expand thespace filling device to occupy approximately 70% of the stomach volume.In an embodiment, the device includes a remote control 300 that thesubject uses to expand or collapse the device. See FIG. 3A.

In an embodiment, the system 100 includes a stomach volume reducingdevice with one or more hunger control delivery reservoirs 128. See, forexample, FIG. 4. In an embodiment, the stomach volume reducing device isconfigured for implantation within an subject, optionally including oneor more hunger control delivery reservoirs 128.

In an embodiment, the stomach volume reducing device includes one ormore power sources 116, which may be operably coupled to one or morecomponents of the stomach volume reducing device or the device as awhole. In an embodiment, a hunger control delivery reservoir 128 isoperably coupled to one or more batteries 120. In an embodiment, abattery 120 includes a thin-film fuel cell for providing electricalpower. In an embodiment, the fuel cell is of a solid oxide type (SOFC),a solid polymer type (SPFC), a proton exchange membrane type (PEMFC),and/or substantially any combination thereof. Methods to fabricate suchthin-film fuel cells are known and have been described (e.g., U.S. Pat.No. 7,189,471), incorporated herein by reference. In an embodiment, oneor more batteries 120 include one or more storage films that areconfigured for energy storage and energy conversion. Methods tofabricate such storage films are known and have been described (e.g.,U.S. Pat. No. 7,238,628), incorporated herein by reference. In anembodiment, a battery 120 is a biobased battery 120 (e.g., U.S. Pat. No.6,994,934, incorporated herein by reference). In an embodiment, thebattery includes at least one inductive recharger or similar internalcharger 121.

In an embodiment, one or more batteries 120 are thin-film batteries 120.Methods to fabricate thin-film batteries 120 are known and have beendescribed (e.g., U.S. Pat. Nos. 7,194,801; 7,144,655; 6,818,356,incorporated herein by reference). In an embodiment, one or moreelectromagnetic receivers 118 are used to electromagnetically couplepower to energize one or more hunger control delivery reservoirs 128from an external power source 116. Methods to construct electromagneticreceivers 118 have been described (e.g., U.S. Pat. No. 5,571,152),incorporated herein by reference. Briefly, in an embodiment, one or moreelectromagnetic receivers 118 may be operably coupled to one or morerectifier chips. The one or more electromagnetic receivers 118 includeone or more cores about which are wrapped in an electrical conductor. Inan embodiment, cores comprise a material, such as a ferrite material,due to its relatively high magnetic permeability and low magnetichysteresis. However, other materials can be used for this purpose. In anembodiment, a hunger control delivery reservoir 128 is operably coupledto one or more capacitors 122. In an embodiment, one or moreelectromagnetic receivers 118 are operably coupled to one or morebatteries 120. In an embodiment, one or more electromagnetic receivers118 are operably coupled to one or more capacitors 122. Accordingly, inan embodiment, one or more hunger control delivery reservoirs 128 areconfigured such that they are operably coupled to a rechargeable powersource 116.

In an embodiment, wireless transmission may serve as a means to powerthe system, including the external device. See U.S. Patent App. Pub. No.2005/0143787, which is incorporated herein by reference.

In an embodiment, a hunger control delivery reservoir 128 is operablycoupled to one or more hunger control units 146. In an embodiment, theone or more hunger control units 146 serve to regulate the activity ofone or more hunger control delivery reservoirs 128. For example, in anembodiment, one or more hunger control units 146 regulate one or moretimes when one or more hunger control delivery reservoirs 128 administerone or more appetite suppressants 162. In an embodiment, one or morehunger control units 146 regulate one or more time periods when one ormore hunger control delivery reservoirs 128 administer one or moreappetite suppressants 162 to control hunger. In an embodiment, one ormore hunger control units 146 regulate what appetite suppressants 162are administered by one or more hunger control delivery reservoirs 128.In an embodiment, one or more hunger control units 146 regulate theoperation of one or more reservoir motors 156 operably coupled to one ormore hunger control delivery reservoirs 128. For example, in anembodiment, one or more control units 146 regulate the duration ofoperation of one or more reservoir motors 156. In an embodiment, one ormore hunger control units 146 regulate the time when one or morereservoir motors 156 are operated. In an embodiment, one or more hungercontrol units 146 regulate the frequency with which one or more motors156 are operated. In an embodiment, one or more hunger control units 146are operably coupled to one or more processors 148. In an embodiment,one or more hunger control delivery reservoirs 128 include a processor148 configured to process information received from one or more sensors102. For example, in an embodiment, one or more processors 148 areconfigured to calculate the concentration of one or more detected pH orelectrical signals from the subject. In an embodiment, one or moreprocessors 148 is configured to determine changes in the concentrationor source of one or more of detected pH or electrical signals from thesubject relative to time. In an embodiment, one or more processors 148are configured to regulate one or more motors 156 that are operablycoupled to the hunger control delivery reservoirs 128. For example, inan embodiment, one or more processors 148 facilitate operation of one ormore motors 156 to administer one or more amounts of one or moreappetite suppressants 162. In an embodiment, one or more processors 148facilitate operation of one or more motors 156 to administer one or moreappetite suppressants 162 at one or more times. In an embodiment, one ormore processors 148 facilitate operation of one or more motors 156 toadminister one or more amounts of one or more appetite suppressants 162at one or more times. In an embodiment, one or more processors 148include delivery logic 150. For example, in an embodiment, one or moredelivery processors 148 include delivery logic 150 that is programmed tofacilitate administration of one or more appetite suppressants 162 to ansubject. In an embodiment, one or more delivery processors 148 includedelivery logic 150 that is programmed to facilitate administration ofone or more appetite suppressants 162 to an subject such that theconcentration of the one or more appetite suppressants 162 issubstantially maintained at a set point. In an embodiment, one or moredelivery processors 148 include delivery logic 150 that is programmed tofacilitate administration of one or more appetite suppressants 162 to ansubject such that the concentration of the one or more appetitesuppressants 162 is substantially maintained within a range ofconcentrations. In an embodiment, one or more delivery processors 148include delivery logic 150 that is programmed to facilitateadministration of one or more appetite suppressants 162 to an subjectwith regard to characteristics of the subject, particularly hunger orfood cravings. For example, in an embodiment, delivery logic 150accounts for the size of an subject to facilitate administration of oneor more appetite suppressants 162 to an subject. In an embodiment, acontrol unit 146 includes hunger control delivery memory 152. Forexample, in an embodiment, one or more hunger control deliveryreservoirs 128 save information operably coupled to the identity of oneor more administered appetite suppressants 162, the concentration of oneor more administered appetite suppressants 162, changes in theconcentration of one or more appetite suppressants 162, or substantiallyany combination thereof. Numerous types of memory may be used for hungercontrol delivery memory 152. Examples of memory include, but are notlimited to, flash memory, random access memory, read-only memory, andthe like.

In an embodiment, a hunger control delivery reservoir 128 includes oneor more transmitters 154. Numerous types of transmitters 154 may be usedin association with system 100. Examples of such transmitters 154include, but are not limited to, transmitters that transmit one or moreacoustic signals, optical signals, radio signals, wireless signals,hardwired signals, infrared signals, ultrasonic signals, and the like(e.g., U.S. Pat. Nos. RE39,785; 7,260,768; 7,260,764; 7,260,402;7,257,327; 7,215,887; 7,218,900; herein incorporated by reference). Inan embodiment, one or more transmitters 154 may transmit one or moresignals that are encrypted. Numerous types of transmitters are known andhave been described (e.g., U.S. Patent Nos. and Published U.S. PatentApplications: U.S. Pat. No. 7,236,595; U.S. Pat. No. 7,260,155; U.S.Pat. No. 7,227,956; U.S. 2006/0280307; herein incorporated byreference).

A hunger control delivery reservoir 128 includes one or more receivers132. In an embodiment, numerous types of receivers 132 are used inassociation with system 100. Examples of such receivers 132 include, butare not limited to, receivers that receive one or more acoustic signals,optical signals, radio signals, wireless signals, hardwired signals,infrared signals, ultrasonic signals, and the like. Such receivers 132are known and have been described (e.g., U.S. Pat. Nos. RE39,785;7,218,900; 7,254,160; 7,245,894; 7,206,605; herein incorporated byreference).

In an embodiment, the device includes a housing and potentially areservoir. In an embodiment, one or more device housings 140 areoperably coupled with one or more ports 144. In an embodiment, one ormore device housings 140 are operably coupled with one or more motors156. In an embodiment, one or more device housings 140 are operablycoupled with one or more moveable members 158. In an embodiment, the oneor more moveable members include one or more mechanical actuatablemembers 159.

In an embodiment, a device housing 140 may be configured as a tube witha port 144 operably coupled to a distal end of the tube. In anembodiment, such a device housing 140 is configured to accept a moveablemember 158 that is configured to slide within the interior of the devicehousing tube from a proximal end of the tube to the distal end of thetube. In an embodiment, the moveable member 158 is operably coupled toone or more motors 156 that are configured to translocate the moveablemember 158. In an embodiment, the space within the tube between themoveable member 158 and the port 144 is configured as a reservoir 128that included one or more appetite suppressants 162. Accordingly,movement of the moveable member 158 from the proximal end to the distalend of the tube will cause the one or more appetite suppressants 162 tobe expelled from the port 144. In an embodiment, numerous types ofmotors 156 can be operably coupled to one or more hunger controldelivery reservoirs 128. Examples of such motors 156 include, but arenot limited to, stepper motors 156, osmotic motors 156, piezoelectricmotors 156, ultrasonic motors 156, acoustic motors 156, and the like. Inan embodiment, one or more moveable members 158 can be operably coupledto one or more ratcheted members such that the one or more moveablemembers 158 can be engaged by the one or more ratcheted members inconjunction with movement facilitated by one or more motors 156.

One or More Sensors

As illustrated in FIG. 4, in an embodiment, a system 100 includes one ormore sensors 102. In an embodiment, one or more sensors 102 may beconfigured for implantation within an subject (e.g., U.S. Pat. Nos.7,110,803 and 7,044,911, each of which is incorporated herein byreference). Sensors 102 may be configured for implantation at numerouspositions within an subject. For example, in an embodiment, one or moresensors 102 may be configured for implantation into the vasculature ofan subject (e.g., U.S. Pat. Nos. 7,181,261; 7,025,734; and 7,236,821,each of which is incorporated herein by reference).

In an embodiment, the one or more sensors 102 include at least onefiber-optic sensor. In an embodiment, the one or more sensors 102include at least one fiber-optic wave-based biosensor. In an embodiment,the one or more sensors 102 include at least one protein sensor. See,for example, Preejith, et al. Biotech. Lett. 25: 105-110 (2003), whichis incorporated herein by reference.

In an embodiment, the one or more sensors 102 include at least one fiberoptic sugar sensor. See, for example, Kumar, et al., Pramana J. of Phys.Vol. 67, No. 2, 383-387 (2006), which is incorporated herein byreference.

In an embodiment, the one or more sensors 102 include at least onepolymethylmethacrylate fiber sensor.

In an embodiment, the one or more sensors 102 include at least onechemical sensor configured to detect at least one chemical, temperature,pressure, or electrical condition of the subject (e.g., presence ofsugar, presence of protein, pH, presence of carbon dioxide or othergases, presence of at least one enzyme, nerve signals originating fromthe subject, etc.). In an embodiment, at least one chemical orelectrical condition sensor is operably coupled to the port. In anembodiment, a port is responsive to the sensed chemical or electricalcondition by the at least one chemical or electrical condition sensor.In an embodiment, the chemical sensor is a chemical sensor.

In an embodiment, a sensor 102 is operably coupled to one or more sensorcontrol units 104. In an embodiment, the one or more sensor controlunits 104 serve to regulate the activity of the one or more sensors 102.For example, in an embodiment, one or more sensor control units 104regulate one or more times when the one or more sensors 102 detect oneor more of pH or electrical signals from the subject. In an embodiment,the one or more sensor control units 104 regulate one or more timeperiods when one or more sensors 102 detect one or more of pH orelectrical signals from the subject. In an embodiment, one or moresensor control units 104 are operably coupled to one or more detectionprocessors 106. In an embodiment, one or more sensors 102 include adetection processor 106 that is configured to process informationreceived from one or more detectors 114. For example, in an embodiment,one or more detection processors 106 are configured to calculate theconcentration of one or more of detected pH, chemical chemicals, orelectrical (nerve) signals from the subject. In an embodiment, one ormore detection processors 106 are configured to determine changes in theconcentration of one or more detected pH, chemical chemicals, or nervesignals from the subject relative to time. In an embodiment, one or moredetection processors 106 are configured to prepare one or moreinstructions for one or more hunger control delivery reservoirs 128. Forexample, in an embodiment, one or more detection processors 106 instructone or more hunger control delivery reservoirs 128 to administer one ormore amounts of one or more appetite suppressants 162.

In an embodiment, the at least one intelligent polymer includes apolymer conjugated to recognize at least one protein (e.g., antibody,enzyme, etc.). Such intelligent polymers are bioconjugated, for example,by random polymer conjugation to lysine amino groups on the proteinsurface, or by site-specific conjugation of the polymer to specificamino acid sites (e.g., cysteine sulfhydryl groups) that are engineeredinto the known amino acid sequence of the protein. See, for example,Hoffman, Am. Assoc. for Clin. Chem. on the worldwide web atclinchem.org/content/46/9/1478.full, accessed on Jan. 6, 2012, thecontent of which is incorporated herein by reference.

In an embodiment, one or more detection processors 106 instruct one ormore hunger control delivery reservoirs 128 to administer one or moreappetite suppressants 162 at one or more times. In an embodiment, one ormore detection processors 106 instruct one or more hunger controldelivery reservoirs 128 to administer one or more amounts of one or morehunger control delivery reservoirs 128 at one or more times. In anembodiment, one or more detection processors 106 include detection logic108. For example, in an embodiment, one or more detection processors 106include detection logic 108 that is programmed to compensate forbackground occurring during detection of one or more of pH, chemicalpresence or levels, or nerve signals from the subject. In an embodiment,detection logic 108 is configured to process information obtained duringdetection of one or more of pH or electrical signals from a subject toaccount for the personal characteristics of the subject into which thesensor 102 is implanted. For example, in an embodiment, detection logic108 is configured to determine the amount of one or more appetitesuppressants 162 to be administered to an subject to maintain theconcentration of the one or more appetite suppressants 162 at one ormore set points within the subject. In an embodiment, detection logic108 is configured to determine the amount of one or more appetitesuppressants 162 to be administered to an subject to maintain theconcentration of the one or more appetite suppressants 162 within one ormore concentration ranges within the subject. In an embodiment, a sensorcontrol unit 104 may include detection memory 110. For example, in anembodiment, one or more sensors 102 save information operably coupled tothe identity of one or more detected pH, chemical, or nerve signals fromthe subject, the pH level, the source of the nerve signals from thesubject, changes in the pH, changes in the type or amount of chemicalchemicals present, or nerve signals from the subject, or substantiallyany combination thereof. Numerous types of memory may be used fordetection memory 110. Examples of memory include, but are not limitedto, flash memory, random access memory, read-only memory, and the like.In an embodiment, circuitry is configured to operate one or more ports,or the reversibly responsive expandable device housing. In anembodiment, the circuitry configured to operate the reversiblyresponsive expandable device housing includes circuitry for operatingone or more energy storage devices. In an embodiment, circuitryconfigured to operate the reversibly responsive expandable devicehousing includes circuitry for operating one or more transmitters. In anembodiment, control circuitry is configured to determine when to engageat least one motor 156 of the device.

In an embodiment, a sensor 102 is configured to wirelessly communicatesensed electrical signals originating from a subject. In an embodiment,a sensor 102 is electrically or optically coupled to the controlcircuitry to communicate the one or more signals thereto. In anembodiment, the control circuitry is configured to determine when toengage the chemical or electrical condition responsive matrix.

In an embodiment, a sensor 102 includes one or more sensor housings 184.In an embodiment, one or more sensor housings 184 are operably coupledwith one or more detectors 114.

In an embodiment, numerous types of detectors 114 may be operablycoupled to the one or more sensors 102. In an embodiment, the one ormore sensors include at least one detector and reporter. In anembodiment, numerous different types of detectors 114 are operablycoupled to one or more sensors 102. Examples of such detectors 114include, but are not limited to, electrodes, surface plasmon resonancedetectors 114, microelectromechanical systems detectors 114,microcantilever detectors 114, nitric oxide detectors 114, osmoticdetectors 114, relativity-based detectors 114, chemical detectors 114,pressure detectors 114, electrochemical detectors 114, piezoelectricdetectors 114, pH detectors 114, hydrogel detectors 114, enzymaticdetectors 114, ball integrated circuit detectors 114, affinityviscosimetric detectors 114, blood pressure detectors 114; metaldetectors 114, glucose detectors 114, and the like (e.g., U.S. Pat. Nos.7,162,289; 6,280,604; 5,603,820; 5,582,170; 6,287,452; 7,291,503;6,764,446; 7,168,294; 6,823,717; 7,205,701; 6,268,161; 4,703,756;6,965,791; 6,546,268; 6,210,326; 6,514,689; 6,234,973; 6,442,413; Tu etal., Electroanalysis, 11:70-74 (1999), Malinski et al., MolecularMechanisms of Metal Toxicity and Carcinogenicity, Environmental HealthPerspectives 102, Supplement 3, September 1994, each of which isincorporated herein by reference). In an embodiment, one or moredetectors 114 are configured to detect one or more of pH, chemicals, ornerve signals from the subject.

In an embodiment, one or more sensor housings 184 include circuitry thatis operably coupled to one or more detectors 114. In an embodiment, oneor more sensor housings 184 include circuitry that is configured tofacilitate elimination of one or more sacrificial layers. In anembodiment, one or more sensor housings 184 include circuitry that isconfigured to facilitate reconfiguration of one or more shape memorymaterials. In an embodiment, one or more sensor housings 184 includecircuitry that is configured to be operably coupled to one or moredetectors 114. In an embodiment, one or more sensor housings 184 includecircuitry that is configured to be operably coupled to one or moresensor control units 104. In an embodiment, one or more sensor housings184 include circuitry that is configured to be operably coupled to oneor more sensor power sources 116. In an embodiment, one or more sensorhousings 184 include circuitry that is configured to be operably coupledto one or more sensor receivers 132. In an embodiment, one or moresensor housings 184 include circuitry that is configured to be operablycoupled to one or more sensor transmitters 126.

In an embodiment, a sensor 102 includes one or more sensor power sources116. In an embodiment, a sensor 102 is operably coupled to one or moresensor batteries 120. In an embodiment, a sensor battery 120 includes athin-film fuel cell for providing electrical power. In an embodiment,the fuel cell is of a solid oxide type (SOFC), a solid polymer type(SPFC), a proton exchange membrane type (PEMFC), and/or substantiallyany combination thereof. Methods to fabricate such thin-film fuel cellsare known and have been described (e.g., U.S. Pat. No. 7,189,471,incorporated herein by reference). In an embodiment, one or more sensorbatteries 120 include one or more storage films that are configured forenergy storage and energy conversion. Methods to fabricate such storagefilms are known and have been described (e.g., U.S. Pat. No. 7,238,628,incorporated herein by reference). In an embodiment, a sensor battery120 is a biobased battery (e.g., U.S. Pat. No. 6,994,934, incorporatedherein by reference). In an embodiment, one or more sensor batteries 120are thin-film batteries. Methods to fabricate thin-film batteries,including thin film microbatteries, are known and have been described(e.g., U.S. Pat. Nos. 5,338,625, 7,194,801; 7,144,655; 6,818,356,incorporated herein by reference). In an embodiment, one or more sensorelectromagnetic receivers 118 is used to electromagnetically couplepower to energize one or more sensors 102 from an external power source116. Methods to construct electromagnetic receivers 118 have beendescribed (e.g., U.S. Pat. No. 5,571,152). In an embodiment, thereceiver and/or transmitter are not part of the sensor.

Briefly, in an embodiment, one or more electromagnetic receivers 118 areoperably coupled to one or more rectifier chips. In an embodiment, theone or more sensor electromagnetic receivers 118 include one or morecores about which are wrapped an electrical conductor. In an embodiment,cores comprise a material, such as a ferrite material, due to itsrelatively high magnetic permeability and low magnetic hysteresis.However, other materials can be used for this purpose. In an embodiment,a sensor 102 is operably coupled to one or more capacitors 122. In anembodiment, one or more sensor electromagnetic receivers 118 areoperably coupled to one or more sensor batteries 120. In an embodiment,one or more sensor electromagnetic receivers 118 are operably coupled toone or more capacitors 122. Accordingly, in an embodiment, one or moresensors 102 are configured such that they are operably coupled to arechargeable power source 116.

In an embodiment, the system 100 includes one or more sensortransmitters 126. Numerous types of transmitters 126 can be used inassociation with system 100. Examples of such transmitters 126 include,but are not limited to, transmitters that transmit one or more acousticsignals, optical signals, radio signals, wireless signals, hardwiredsignals, infrared signals, ultrasonic signals, and the like (e.g., U.S.Pat. Nos. RE39,785; 7,260,768; 7,260,764; 7,260,402; 7,257,327;7,215,887; 7,218,900), incorporated herein by reference. In anembodiment, one or more sensor transmitters 126 may transmit one or moresignals that are encrypted. Numerous types of transmitters are known andhave been described (e.g., U.S. Patent Nos. and Published U.S. PatentApplications: U.S. Pat. No. 7,236,595; U.S. Pat. No. 7,260,155; U.S.Pat. No. 7,227,956; U.S. 2006/0280307), in corporate herein byreference.

In an embodiment, the system 100 includes one or more sensor receivers132. Numerous types of sensor receivers 132 may be used in associationwith system 100. Examples of such sensor receivers 132 include, but arenot limited to, receivers that receive one or more acoustic signals,optical signals, radio signals, wireless signals, hardwired signals,infrared signals, ultrasonic signals, and the like. Such receivers 132are known and have been described (e.g., U.S. Pat. Nos. RE39,785;7,218,900; 7,254,160; 7,245,894; 7,206,605), incorporated herein byreference.

Signal

In an embodiment, numerous types of signals can be used in associationwith a system 100. In an embodiment, a signal may be an internal signal160. In an embodiment, a signal may be an external sensor signal 166. Inan embodiment, a signal can be an external device signal 170. In anembodiment, a signal can be an interface signal 186. In an embodiment, asignal can be an external signal 188. Examples of such signals include,but are not limited to, analog signals, digital signals, acousticsignals, optical signals, radio signals, wireless signals, hardwiredsignals, infrared signals, ultrasonic signals, and the like. In anembodiment, one or more signals may not be encrypted. In an embodiment,one or more signals may be encrypted. In an embodiment, one or moresignals may be sent through use of a secure mode of transmission. In anembodiment, one or more signals may be coded for receipt by a specificsubject. In an embodiment, such code may include anonymous code that isspecific for an subject. Accordingly, information included within one ormore signals may be protected against being accessed by others who arenot the intended recipient.

In an embodiment, one or more signals include information operablycoupled to the operation of one or more hunger control deliveryreservoirs 128. In an embodiment, the one or more hunger controldelivery reservoirs 128 are refillable. For example, in an embodiment,the reservoir includes a magnet that allows the reservoir to bemanipulated from either internal or external to the subject's stomach.The magnet allows for location and manipulation of the reservoir suchthat it can be refilled from an external catheter or other refillablemechanism. In an embodiment, one or more signals include informationoperably coupled to the operation of one or more motors 156 operablycoupled to a hunger control delivery reservoir 128. For example, in anembodiment, one or more signals include information operably coupled tothe operation of one or more motors 156 operably coupled to a hungercontrol delivery reservoir 128. Examples of such information include,but are not limited to, the number of cycles that a motor 156 is tooperate, the number of steps that a motor 156 is to operate, theduration of time for which a motor 156 is to operate, the rate at whicha motor 156 is to operate, one or more times when a motor 156 is tooperate, and the like. Such information may be operably coupled tonumerous types of motors 156. In an embodiment, one or more signalsinclude information that is operably coupled to the operation of one ormore ports that are operably coupled to one or more hunger controldelivery reservoirs 128. In an embodiment, one or more signals includeinstructions for a hunger control delivery reservoir 128 to open one ormore ports. In an embodiment, one or more signals include instructionsfor the device to close one or more ports. Examples of such portsinclude, but are not limited to, electromagnetic ports, shape memoryports, and the like (e.g., Low et al., Sensors and Actuators B:Chemical, 76:149-160 (2000), Pan et al., Proceedings of the 26^(th)Annual International Conference of the IEEE EMBS, San Francisco, Calif.,USA, Sep. 1-5 (2004), U.S. Pat. No. 6,454,759, each of which isincorporated herein by reference). In an embodiment, such ports may beoperably coupled to one or more osmotic motors 156. In an embodiment,one or more ports may be opened and/or closed to regulate entry of fluidinto one or more chambers of an osmotic motor 156 to control theoperation of the motor 156. For example, in an embodiment, one or moreports may be opened to allow fluid to enter into one or more chambers ofan osmotic motor 156 to facilitate movement of one or more moveablemembers 158 that facilitate extrusion of one or more appetitesuppressants 162 from the hunger control delivery reservoir 128. In anembodiment, the one or more ports may be maintained in an open positionto provide for entry of fluid into one or more chambers of the osmoticmotor 156 or the ports may be closed to disallow entry of fluid into oneor more chambers of the osmotic motor 156. Accordingly, in anembodiment, one or more signals may be received by one or more hungercontrol delivery reservoirs 128 that provide the one or more hungercontrol delivery reservoirs 128 with instructions operably coupled tothe delivery of one or more appetite suppressants 162.

Appetite Suppressants

In an embodiment, numerous types of appetite suppressants 162 are usedwithin system 100 to control hunger in a subject. Examples of suchappetite suppressants include but are not limited to leptin, exendin-4,peptide YY, caffeine, cholecystokinin, pancreatic polypeptide,glucagon-like peptide-1, glucagon-like peptide-2, oxyntomodulin,motilin, PHI/PHV, PPY3-36, somatostatin, proopiomelanocortin, chitosan,or a similar agent.

In an embodiment, the at least one appetite suppressant is included withchemical or electrical condition responsive matrix (including, but notlimited to responsive particles). In an embodiment, the chemicalresponsive matrix includes at least one hydrogel. In an embodiment, thechemical responsive matrix is formulated for gradual release of theappetite suppressant from the matrix. In an embodiment, the chemicalresponsive matrix is formulated to release the appetite suppressant byway of diffusion or dissolution of the matrix. In an embodiment, thechemical responsive matrix is coated in at least one appetitesuppressant. In an embodiment, the chemical responsive matrix includesparticles formulated to expand in the presence of a particular pH range.

FIG. 5 illustrates embodiment 500 of a stomach-volume-reducing deviceincluding reversibly responsive expandable device housing 199 encasingenvironmental condition responsive polymeric particles responsive to atleast one environmental condition, and which optionally includes atleast one hunger control delivery reservoir 128 within system 100. InFIG. 5, discussion and explanation may be provided with respect to theabove-described example of FIG. 4 and/or with respect to other examplesand contexts. However, it should be understood that the modules mayexecute operations in a number of other environments and contexts,and/or modified versions of FIG. 4. Also, although the various modulesare presented in the sequence(s) illustrated, it should be understoodthat the various modules may be configured in numerous orientations.

The embodiment 500 may include module 510 that includes a reversiblyresponsive expandable device housing 199 encasing a responsive polymericmatrix that is responsive to at least one chemical, including pH,chemical, or nerve signal.

The embodiment 500 may include module 520 that includes a port that isconfigured in numerous possible ways. For example, in an embodiment, atleast one port 144 may be configured as a slit valve (e.g., U.S. Pat.No. 6,217,906, incorporated herein by reference). In an embodiment, oneor more slit valves may be electrically controllable. For example, in anembodiment, a slit valve may include a locking member that is underelectrical control. In an embodiment, such a locking member may be anelectromagnetically controlled bar that is configured to lock a slitvalve in a closed position. In an embodiment, one or more ports 144 mayinclude a shape memory material. In an embodiment, one or more ports 144may include a shape memory material that is electrically controllable.For example, in an embodiment, one or more ports 144 may include one ormore shape memory materials that open when heated. In an embodiment, oneor more ports 144 may include one or more shape memory materials thatopen when heated with an electrical coil. Accordingly, in an embodiment,such ports 144 may be opened and/or closed through application ofelectric current to a heating coil operably coupled to the port 144. Inan embodiment, one or more ports 144 may include one or moreelectromagnetic closures. Electromagnetic closures may be configured innumerous possible ways. In an embodiment, an electromagnetic closure mayinclude a plug that is configured to eliminate flow through a port 144.The plug may be operably coupled to a spring such that the plug isforced into a port 144 by the spring. The plug may be removed from theport 144 through application of a magnetic field to the plug through useof an electromagnet. Accordingly, flow through the port 144 may becontrolled through application of a magnetic field to the plug. In anembodiment, an electromagnetic closure for a port 144 may include ahatchway mechanism wherein a door that covers the port 144 may be openedthrough application of a magnetic field to the door. In embodiment,ports 144 may be configured to facilitate exit of one or more appetitesuppressants 162 from a hunger control delivery reservoir 128.

The embodiment 500 may include module 530 that includes at least onehunger control delivery reservoir with optional hunger control deliveryunits.

The embodiment 500 may include module 540 that includes at least onecontrollable micropump 123 or controllable valve 125 operably connectedto the at least one port 144. In an embodiment, the at least onecontrollable micropump 123 or controllable valve 125 is operablyconnected to at least one transmitter 154 or receiver 118. In anembodiment, the at least one controllable micropump 123 or controllablevalve 125 is operably connected to circuitry configured for control ofthe at least one controllable micropump 123 or controllable valve 125.In an embodiment, the at least one controllable micropump 123 orcontrollable valve 125 is operably connected to circuitry configured forwireless control of the at least one controllable micropump 123 orcontrollable valve 125.

FIG. 6 illustrates an embodiment 600 that may include module 610 thatincludes at least one reversibly responsive expandable device housing199 configured to attach to a gastric wall of a subject (e.g., by way ofa suture, hook, or pin). In an embodiment, module 620 may include atleast one motor 156. In an embodiment, one or more motors 156 may beoperably coupled to one or more actuatable mechanical members 159through a threaded member 141 or lever member 555. In an embodiment, oneor more motors 156 may be configured to turn one or more threaded member141 or lever member 555 (See FIG. 5), to cause movement of one or moreactuatable mechanical members 159. In an embodiment, one or more motors156 may be operably coupled to one or more actuatable mechanical members159 through a ratchet member 111. In an embodiment, one or more motors156 may be configured to advance the one or more ratchet members 111 tocause movement of one or more actuatable mechanical members 159. In anembodiment, the at least one actuatable mechanical member 159 includesat least one linear displacement actuator within the member. In anembodiment, the at least one actuatable mechanical member 159 includesat least one shape memory alloy. See, for example, U.S. Pat. Nos.7,931,693 and 8,021,384, each of which is incorporated herein byreference. In an embodiment, module 630, the device includes at leastone sensor.

Accordingly, as shown in FIG. 5, in an embodiment one or more motors 156may be calibrated to advance one or more actuatable mechanical members159 a certain distance to increase the volume of the stomach-volumereducing device. In an embodiment, one or more motors 156 facilitaterelease of one or more appetite suppressants 162 from an optional hungercontrol delivery reservoir 128. A hunger control delivery reservoir 128may be operably coupled to numerous types of motors 156. Examples ofsuch motors 156 include, but are not limited to, rotary motors 156,linear motors 156, osmotic motors 156, electric motors 156,piezoelectric motors 156, ultrasonic motors 156, and the like.Accordingly, in an embodiment, one or more motors 156 may be operablycoupled to circuitry that is configured to operate the one or moremotors 156. For example, in an embodiment, circuitry may be configuredto operate one or more motors 156 for a certain period of time tofacilitate administration of one or more appetite suppressants 162 to asubject with whom a hunger control delivery reservoir 128 is associated.In an embodiment, circuitry can be configured to calibrate one or moremotors 156 to facilitate administration of a select amount of one ormore appetite suppressants 162 to a subject with whom a hunger controldelivery reservoir 128 is associated. In an embodiment, the at least onehunger control delivery reservoir includes at least one fluid foractivating the chemical responsive matrix, and at least one opening influid communication with the chemical responsive matrix. In anembodiment, at least one fluid for activating the chemical responsivematrix includes acidified water.

In an embodiment, as shown in FIG. 5, at least one controller 121 isconfigured to activate expansion of the stomach-volume reducing deviceto a programmed level of expansion. In an embodiment, at least onesensor 102 is operably coupled to at least one motor 156 and isconfigured to wirelessly communicate sensed electrical signalsoriginating from the subject. In an embodiment, the at least one sensor102 is electrically or optically coupled to the control circuitry tocommunicate the one or more signals thereto. In an embodiment, thecontrol circuitry is configured to determine when to engage the at leastone motor 156. In an embodiment, at least one controller 121 isconfigured to activate expansion of the stomach volume reducing deviceresponsive to the control circuitry determining that the at least onereversibly responsive expandable stomach volume reducing device is to bedeployed. In an embodiment, the at least one controller 121 isconfigured to activate expansion of the stomach volume reducing deviceto a programmed level of expansion. In an embodiment, the controlcircuitry is operably coupled to the stomach volume reducing deviceconfigured to operate the at least one motor 156 responsive to receivingone or more signals from the at least one sensor 102 and is configuredto actuate the at least one actuatable mechanical member 159 operablycoupled to the at least one motor 156. In an embodiment, the system 100includes a first data transmitter 154 coupled to the control circuitry,the first data transmitter 154 configured to transmit information atleast related to data encoded in the one or more sensed electricalsignals of the subject. In an embodiment, the first data transmitter 154is configured to wirelessly transmit the information. In an embodiment,the control circuitry is programmable. In an embodiment, the device isprogrammable for expansion of about 5%, about 10%, about 15%, about 20%,about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about90%, about 100%, or any value less than or therebetween. In anembodiment, the device is programmable for expansion at different ratesat different time points. In an embodiment, the device is programmablefor expansion at different levels at different time points. In anembodiment, the control circuitry is configured to direct the datatransmitter 154 to transmit the information to a third part or a seconddevice. In an embodiment, the second device includes a secondstomach-volume-reducing device. In an embodiment, the system includes amemory module configured to store data encoded in the one or more sensedelectrical signals of the subject.

In an embodiment, the control circuitry is operably coupled to thestomach-volume reducing device configured to operate the at least onemotor 156 responsive to receiving one or more signals from the at leastone sensor 102 and is configured to actuate the at least one actuatablemechanical member 159 operably coupled to the at least one motor 156.

In an embodiment, at least one wireless remote controller 121 may beoperably coupled to the at least one motor 156. In an embodiment, atleast one reversibly responsive reversibly responsive expandable devicehousing 199 is made from a first polymer, the reversibly responsivereversibly responsive expandable device housing 199 encasing chemicalresponsive particles made from a second polymer, the reversiblyresponsive reversibly responsive expandable device housing 199 includingat least one port 144; and at least one controllable micropump 123 orcontrollable valve 125 operably connected to the at least one port 144.

FIG. 7 illustrates an embodiment 700 that may include module 710 thatincludes at least one reversibly responsive expandable device housing199 configured to attach to a gastric wall of a subject. In anembodiment, module 720 may include at least one controllable ratchetmember 111 or extendable ladder member 109, threaded member 141, orlever member 555. In an embodiment, module 730 may include at least onemotor 156 (e.g., ultrasonic motor, osmotic motor, piezoelectric motor,stepper motor, rotary motor, etc.), operably coupled to the at least onecontrollable ratchet member 111 or controllable extendable ladder member109. In an embodiment, module 740 may include at least one controlleroperably coupled to the at least one motor 156 and configured toincrease or decrease the length of the controllable ratchet 111 orcontrollable extendable ladder member 109. A controller 121 may beoperably coupled to the at least one motor 156.

FIG. 8 illustrates a partial view of a system 800 that includes acomputer program 802 including a signal bearing medium bearinginstructions for executing a computer process on a computing device. Anembodiment of system 800 is provided using a signal-bearing medium 802bearing one or more instructions 804 for operating one or more motors156 and one or more instructions for operating one or more hungercontrol units 146 that are operably coupled to the one or more motors156 and that are responsive to one or more signals received from one ormore implanted sensors 102. The one or more instructions may be, forexample, computer executable and/or logic-implemented instructions. Inan embodiment, the signal-bearing medium 802 may include acomputer-readable medium 806. In an embodiment, the signal-bearingmedium 802 may include a recordable medium 808. In an embodiment, thesignal-bearing medium 802 may include a communications medium 810. In anembodiment, the module 812 may include one or more instructions foroperating one or more ports 144. In an embodiment, a module 814 mayinclude one or more instructions for operating one or more reversiblyresponsive reversibly expandable device housings.

FIG. 9 illustrates a partial view of a system 900 that includescircuitry 902 configured to operate at least one controllable ratchetmember 111 or controllable extendable ladder member 109. In anembodiment, the system 900 includes circuitry 904 configured to operateone or more motors 156 operably coupled to the at least one controllableratchet member 111 or controllable extendable ladder member 109. In anembodiment, the system 900 includes at least one controller 905 operablycoupled to the one or more motors 156 and configured to increase ordecrease the length of the controllable ratchet member 111 or extendableladder member 109.

FIG. 10 illustrates a partial view of a system 1000 that includes astomach volume reducing device 1002 including at least one reversiblyresponsive expandable device housing 199 encasing chemical responsiveparticles. In an embodiment, the reversibly responsive expandable devicehousing 199 includes at least one port 144. In an embodiment, the system1000 includes at least one controllable micropump 123 or controllablevalve 125 operably connected to the at least one port 144. In anembodiment, the system 1000 includes at least one sensor 102 configuredto sense at least one nerve signal originating from the subject. In anembodiment, the system 1000 includes control circuitry operably coupledto the stomach volume reducing device, the control circuitry configuredto operate the at least one port 144 responsive to receiving one or moresignals from the at least one sensor 102. In an embodiment, the sensor102 includes at least one blood pressure cuff.

In an embodiment, the sensor detector component is configured to detecta chemical, pH, or nerve signal.

In an embodiment, the stomach volume reducing device includes one ormore hunger control delivery reservoirs 128 that are operably coupled tothe one or more ports 144. Device housings 140 may be configured innumerous ways. In an embodiment, a device housing 140 may include one ormore hunger control delivery reservoirs 128. In an embodiment, a devicehousing 140 may include one or more motors 156. In an embodiment, adevice housing 140 includes at least one port 144. In an embodiment, adevice housing 140 may include one or more entry ports 222. In anembodiment, a device housing 140 may include one or more exit ports 223.In an embodiment, the at least one port 144 includes one or moreintelligent responsive matrix that is responsive to one or moreenvironmental condition including at least one of a chemical, pressure,temperature, acoustic signals (e.g., stomach grinding, hiccups, etc.),or electrical signals.

A device housing 140 may be fabricated from numerous types of materials.Examples of such materials include, but are not limited to, metals,elastic chemicals, ceramics, plastics, polymer, nitrile, silicon,cellulose-based plastic, and substantially any combination thereof. Inan embodiment, the device housing 140 includes a reversibly responsiveexpandable device housing 199, for example, includeslactide-glycolide-caprolactone. In an embodiment, the reversiblyresponsive expandable device housing 199 includes chitosan. In anembodiment, the device housing 199 includes chitosan on at least oneexternal interface. In an embodiment, the reversibly responsiveexpandable device housing 199 includes a colloid responsive to acarbohydrate. In an embodiment, the device housing expands responsivelybased on the matrix housed therein. In an embodiment, the reversiblyresponsive expandable device housing 199 is encased in a container 223.In an embodiment, the container 223 includes an reversibly responsiveexpandable mesh. In an embodiment, a hunger control delivery reservoir128 may be configured for implantation within a subject. In anembodiment, a hunger control delivery reservoir 128 may be configuredfor placement within a body cavity of a subject. In an embodiment, thereversibly responsive expandable device housing 199 includes a polymerformed by a three dimensional model. In an embodiment, the threedimensional model includes a computer generated model. In an embodiment,the reversibly responsive expandable device housing 199 is formed usinga three dimensional printer.

In an embodiment, the reversibly responsive expandable device housing199 is sized for eventual passage through the gastrointestinal tract ofa subject. In an embodiment, the device housing 199 is sized for oraladministration to a subject. In an embodiment, the device housing 199 isnon-toxic.

In an embodiment, the device includes two or more reversibly responsiveexpandable device housings. In an embodiment, the device housings arenon-toxic.

In an embodiment, the reversibly responsive expandable device housing199 is at least one of biodegradable or biocompatible. In an embodiment,the reversibly responsive expandable device housing 199 includesmultiple layers of biodegradable material. In an embodiment, each layerof the multiple layers of biodegradable material is responsive todegradative chemicals. In an embodiment, the degradative chemicalsinclude at least one of an acidic environment, specific protease,exogenously added compound, or pressure. In an embodiment, degradationof one or more layers of the reversibly responsive expandable devicehousing is predetermined. In an embodiment, the degradation of one ormore layers of the reversibly responsive expandable device housing 199is directed by at least one of a sensor 102 or wireless controller 121.

In an embodiment, the device includes one or more motors 156. In anembodiment, the one or more motors include one or more rotary motors156. In an embodiment, a rotary motor 156 may operate by impartingangular motion to a rotating structure, such as a shaft. In anembodiment, a rotary motor 156 may operate by imparting angular motionto the motor 156 itself. For example, in an embodiment, a rotary motor156 may be operably coupled to an immobile threaded structure such thatrotation of the rotary motor 156 on the threaded structure will causethe motor 156 to advance on the threaded structure. In an embodiment, arotary motor 156 that is operably coupled to a hunger control deliveryreservoir 128 may be calibrated to administer a select amount of one ormore appetite suppressants 162 from the hunger control deliveryreservoir 128 to a subject. For example, in an embodiment, a rotarymotor 156 may be calibrated to rotate a threaded member 141, or levermember 555 a certain number of times in order to advance an associatedmoveable member 158 to facilitate administration of an amount of one ormore appetite suppressants 162 to a subject. Numerous types of rotarymotors 156 may be operably coupled to a hunger control deliveryreservoir 128. Examples of such rotary motors 156 include, but are notlimited to, electric motors 156, piezoelectric motors 156, ultrasonicpiezomotors 156, and the like. Such motors 156 have been described(e.g., Spanner, Survey of the Various Operating Principles of UltrasonicPiezomotors, White Paper for ACTUATOR 2006, Newscale Technologies, Inc.,Victor, N.Y.; Biophan Technologies, Inc., Pittsford, N.Y.; PI (PhysikInstrumente) L.P., Auburn, Mass.), incorporated herein by reference.

As shown in the Figures, in an embodiment, one or more motors 156 mayinclude one or more linear motors 156. In embodiment, a linear motor 156may operate by imparting substantially linear motion to a moveablestructure. For example, in an embodiment, a linear motor 156 may cause amoveable structure to move in a forward motion, a reverse motion,alternately in a forward and reverse direction, or substantially anycombination thereof. In an embodiment, one or more linear motors 156 maybe operably coupled to one or more moveable structures that areconfigured as one or more ratchet members. Accordingly, in anembodiment, one or more moveable structures may be operably coupled withone or more moveable members 158 such that operation of one or morelinear motors 156 will advance the position of one or more moveablemembers 158 on the one or more ratchet members. Accordingly, in anembodiment, a linear motor 156 that is operably coupled to a hungercontrol delivery reservoir 128 may be calibrated to administer a selectamount of one or more appetite suppressants 162 from the hunger controldelivery reservoir 128 to a subject. For example, in an embodiment, alinear motor 156 may be calibrated to move a ratchet member a certainnumber of times in order to administer an amount of one or more appetitesuppressants 162 to a subject.

In an embodiment, one or more motors 156 may include one or morepiezoelectric motors 156. Numerous types of piezoelectric motors 156 maybe operably coupled to one or more hunger control delivery reservoirs128. In an embodiment, one or more linear piezoelectric motors 156 maybe operably coupled to a hunger control delivery reservoir 128. In anembodiment, one or more rotary piezoelectric motors 156 may be operablycoupled to a hunger control delivery reservoir 128. In an embodiment,one or more ultrasonic piezomotors 156 may be operably coupled to ahunger control delivery reservoir 128. In an embodiment, one or morepiezoelectric stepper motors 156 may be operably coupled to a hungercontrol delivery reservoir 128.

In an embodiment, one or more motors 156 may include one or more steppermotors 156. Stepper motors 156 may be configured in numerous ways. Forexample, in an embodiment, a stepper motor 156 may be configured as anelectro-mechanical device. In an embodiment, a stepper motor 156 may beconfigured as a piezoelectric device. In an embodiment, a hunger controldelivery reservoir 128 may include one or more stepper motors 156 thatare calibrated to facilitate administration of one or more appetitesuppressants 162 to a subject. For example, in an embodiment, a hungercontrol delivery reservoir 128 may include a stepper motor 156 that isoperably coupled to a threaded member 141, lever member 555 that isoperably coupled to one or more moveable members 158. Rotation of thethreaded member 141, lever member 555 by the stepper motor 156 willadvance the moveable member 158 and facilitate administration of one ormore appetite suppressants 162 to a subject from the hunger controldelivery reservoir 128. Accordingly, in an embodiment, operation of astepper motor 156 may rotate a threaded member 141, lever member 555such that a moveable member 158 operably coupled to the threaded member141, lever member 555 is advanced a distance that is directly related tothe angular distance traveled by the threaded member 141, lever member555. Accordingly, in an embodiment, a stepper motor 156 may becalibrated to administer one or more appetite suppressants 162 to asubject. In an embodiment, a stepper motor 156 may be calibrated toadminister one or more appetite suppressants 162 to a subject throughfeedback from one or more sensors 102. For example, in an embodiment, astepper motor 156 may rotate a threaded member 141, lever member 555through a known number of turns to deliver an amount of an appetitesuppressant to a subject and a sensor may determine the concentration ofthe appetite suppressant that was delivered to the subject. The amountof appetite suppressant that was delivered may then be correlated to thenumber of turns of the threaded member 141, lever member 555 and used tocalibrate the stepper motor 156.

In an embodiment, one or more motors 156 may include one or moreultrasonic motors 156. In an embodiment, an ultrasonic motor 156 mayconvert vibrations into linear motion. In an embodiment, an ultrasonicmotor 156 may convert vibrations into rotary motion. Ultrasonic motors156 have been described (e.g., Nanomotion, Inc., Ronkonkoma, N.Y.; PI(Physik Instrumente) L.P., Auburn, Mass.).

In an embodiment, one or more motors 156 may include one or more osmoticmotors 156. The device may include numerous types of osmotic motors 156.Osmotic motors 156 have been described (e.g., U.S. Pat. Nos. 6,454,759;5,112,614; and 7,074,423), incorporated herein by reference. In anembodiment, an osmotic motor 156 may include an osmotic agent that willexpand in size upon contact with fluid. Examples of osmotic agentsinclude, but are not limited to, magnesium sulfate, magnesium chloride,potassium sulfate, sodium chloride, sodium sulfate, lithium sulfate,sodium phosphate, potassium phosphate, d-mannitol, sorbitol, inositol,urea, magnesium succinate, tartaric acid, raffinose, monosaccharides,oligosaccharides, polysaccharides, and substantially any combinationthereof. In an embodiment, an osmotic agent may include one or morehydrophilic polymers that swell upon contact with water. Examples ofsuch polymers include, but are not limited to, poly(hydroxy-alkylmethacrylates); poly(vinylpyrrolidone); anionic and cationic hydrogels;polyelectrolyte complexes; poly(vinyl alcohol); formaldehyde orglutaraldehyde; mixtures of methyl cellulose; cross-linked agar andcarboxymethylcellulose; mixtures of hydroxypropylmethyl-cellulose andsodium carboxymethylcellulose; polymers of N-vinyllactams;polyoxyethylene-polyoxypropylene gels; polyoxybutylene-polyethyleneblock copolymer gels; carob gum; polyacrylic gels; polyester gels;polyurea gels; polyether gels; polyamide gels; polypeptide gels;polyamino acid gels; polycellulosic gels; carbopol acidic carboxypolymers; CYANAMER® polyacrylamides; cross-linked indene-maleicanhydride polymers; GOOD-RITE® polyacrylic acids; POLYOX® Polyethyleneoxide polymers; starch graft copolymers; and Aqua-Keeps acrylate polymerpolysaccharides (e.g., U.S. Pat. No. 7,074,423), incorporated herein byreference.

In an embodiment, one or more hunger control delivery units 146 areoperably coupled to one or more reservoir motors 156. In an embodiment,one or more hunger control delivery units 146 are operably coupled toone or more receivers 118 configured to receive one or more signals fromone or more sensors 102 that are implanted within a subject. One or morehunger control delivery units 146 may include numerous types ofreceivers 118. Examples of receivers 118 include, but are not limitedto, receivers 118 that receive one or more ultrasonic signals, infraredsignals, acoustic signals, optical signals, radio signals, radiofrequency signals, microwave signals, and the like. Receivers 118 mayreceive one or more signals from numerous types of sensors 102. Examplesof sensors 102 include, but are not limited to, sensors 102 that areconfigured to detect one or more chemicals, sensors 102 that areconfigured to detect blood pressure, sensors 102 that are configured todetect carbon dioxide or other gases, sensors 102 that are configured todetect sugar or protein, sensors 102 that are configured to detectpressure, and the like. In an embodiment, one or more hunger controldelivery units 146 may be operably coupled to one or more receivers 118that are configured to receive one or more signals that facilitatecalibration of an associated hunger control delivery reservoir 128. Forexample, in an embodiment, one or more receivers 118 may be configuredto receive one or more signals from one or more sensors 102 that includeinformation related to the concentration of one or more appetitesuppressants 162 within a subject. In an embodiment, the hunger controldelivery unit 146 may then advance one or more moveable members 158 inresponse to the one or more signals. The receiver 118 may then receiveone or more signals from one or more sensors 102 that includeinformation related to the concentration of the one or more appetitesuppressants 162 following administration of the one or more appetitesuppressants 162 to the subject from the hunger Control deliveryreservoir 128. Accordingly, the hunger control delivery unit 146 maythen receive information that may be used to calibrate the hungercontrol delivery reservoir 128 to deliver one or more appetitesuppressants 162 to the subject. In an embodiment, one or more hungercontrol delivery units 146 may receive one or more signals from one ormore sensors 102 that are implanted within a subject. Accordingly, in anembodiment, a hunger control delivery reservoir 128 may act directly inresponse to one or more signals that are transmitted by a sensor that isimplanted within a subject. For example, in an embodiment, a hungercontrol delivery reservoir 128 may receive one or more signals directlyfrom one or more sensors 102 that are implanted within a subject, andmay be included in or on the stomach volume reducing device without thesignals being received and/or transmitted by a transmitter and/orreceiver that is positioned externally to a subject. In an embodiment,the transmitter and/or the receiver 118 is wireless.

In an embodiment, circuitry is configured to operate one or more hungercontrol delivery units 146 that are operably coupled to the at least onemotor 156 and that is responsive to one or more signals received fromone or more sensors 102 of the stomach-volume-reducing device. In anembodiment, the one or more signals include at least one of anultrasonic signal, infrared signal, acoustic signal, optical signal,radio frequency signal, or electromagnetic signal. In an embodiment,control circuitry is configured to operate one or more hunger controldelivery units 146 that are operably coupled to one or more receivers118 that are configured to receive one or more signals that includeinformation related to at least one chemical within a subject.

In an embodiment, the controllable micropump 123 or controllable valve125 is operably connected to at least one transmitter or receiver 118.In an embodiment, the at least one controllable micropump 123 orcontrollable valve 125 is operably connected to at least one energystorage device 130.

In an embodiment, one or more hunger control delivery units 146 that areoperably coupled to the one or more motors 156 may include one or morehunger control delivery units 146 that are operably coupled to one ormore receivers 118 that are configured to receive one or more signalsfrom one or more external interfaces 168. A receiver 118 that isoperably coupled to a hunger control delivery unit 146 may be configuredto receive numerous types of signals. Examples of such signals include,but are not limited to, analog signals, digital signals, acousticsignals, optical signals, radio signals, wireless signals, hardwiredsignals, infrared signals, ultrasonic signals, and the like.

In an embodiment, one or more hunger control delivery units 146 that areoperably coupled to the one or more motors 156 may include one or morehunger control delivery units 146 that act substantially autonomously.For example, in an embodiment, one or more hunger control delivery units146 may include operating instructions that direct the acts of thehunger control delivery unit 146 without external interaction.Accordingly, in an embodiment, a hunger control delivery unit 146 mayinclude memory that includes instructions for operating the hungercontrol delivery unit 146 and a processor 148 that is configured tocarry out the instructions. In an embodiment, the one or more hungercontrol delivery units 146 are configured to receive one or more signalssubstantially continuously from one or more sensors 102. In anembodiment, the one or more hunger control delivery units 146 areconfigured to receive one or more signals that include informationrelated to one or more concentrations of at least one chemical within asubject.

In an embodiment, one or more hunger control delivery units 146 that areoperably coupled to the one or more motors 156 may include one or morehunger control delivery units 146 that are operably coupled to one ormore receivers 118 that are configured to receive one or more infraredsignals. Numerous types of infrared transmitters 126 and receivers 118may be used to send and receive signals. Methods to fabricate infraredtransmitters 126 and receivers 118 are known and have been described(e.g., U.S. Pat. Nos. 4,371,814; 5,359,448 and 5,331,450), hereinincorporated by reference.

In an embodiment, one or more hunger control delivery units 146 that areoperably coupled to the one or more motors 156 may include one or moreappetite delivery control units 146 that are operably coupled to one ormore receivers 118 that are configured to receive one or more signalsthat include information related to one or more concentrations of one ormore appetite suppressants 162 within a subject. For example, in anembodiment, one or more hunger control delivery reservoirs 128 mayinclude one or more receivers 118 that are configured to receive one ormore signals from one or more sensors 102 that are configured to detectcholesterol levels within a subject.

In an embodiment, the device includes a timer 222. In an embodiment, thetimer 222 is operably coupled to a transmitter 154 or receiver 118. Inan embodiment, the timer transmitter 154 or receiver 118 is operablycoupled to at least one motor 156. In an embodiment, the timertransmitter 154 is operably coupled to at least one motor 156 and themotor 156 is operably coupled to a receiver 118. In an embodiment, themotor 156 is responsive to signals received from the timer transmitter154.

FIG. 11 illustrates alternative embodiments of embodiment 200 of hungercontrol delivery reservoir 128 within system 100. For example, in anembodiment, module 1110, the stomach-volume-reducing device includes anenergy storage device (e.g., battery, capacitor, etc.) operably coupledto at least one motor 156. In an embodiment, module 1120, a controller(e.g., wireless remote controller) allows for control of thestomach-volume-reducing device for example, by the subject himself. SeeFIG. 3. In an embodiment, module 1130, the device includes at least oneenvironmental condition sensor (e.g., blood pressure cuff, proteinsensor, gas sensor, sugar sensor, etc.). In an embodiment, module 1140,the stomach-volume-reducing device includes a transmitter. In anembodiment, module 1150, the stomach-volume-reducing device includes areceiver.

In an embodiment, one or more ports 144 may include one or more shapememory closures. Shape memory closures may be fabricated from numeroustypes of material. In an embodiment, one or more shape memory materialsmay be magnetic shape-memory materials. Magnetic shape-memory materialschange shape in response to a magnetic field. Examples of magneticshape-memory materials include, but are not limited to,nickel-manganese-gallium alloys, nickel-titanium alloys,copper-zinc-nickel alloys, and copper-aluminum-nickel alloys. In anembodiment, shape memory materials may be shape memory polymers. In anembodiment, shape memory polymers change shape in response totemperature. In an embodiment, a shape memory polymer may includeoligo(ε-caprolactone)diol and crystallisable oligo(ρ-dioxanone)diol. Inan embodiment, a shape memory polymer may include combinations ofN,N,N′,N′-Tetrakis(2-hydroxypropyl)ethylenediamine (HPED),triethanolamine (TEA), butane diol (BD), and hexamethylene diisocynate(HDI), with the following range of compositions based on 1 molesequivalent of HDI: 0.1 to 0.5 moles HPED, 0 to 0.54 moles of TEA, and 0to 0.40 moles of BD. In an embodiment, shape memory materials may belight-induced shape-memory polymers (Lendlein et al., Letters to Nature,Nature 434:879-882 (2005)), incorporated by reference. Light-inducedshape-memory polymers change shape in response to light.

In an embodiment, one or more ports 144 may include one or more slitvalves. In an embodiment, one or more hunger control delivery devices128 may include one or more slit valves. Slit valves have been described(e.g., U.S. Pat. No. 6,217,906), which is incorporated by reference.

In an embodiment, one or more ports 144 may include one or moreelectromagnetic closures. In an embodiment, one or more hunger controldelivery reservoirs 128 may include one or more electromagneticclosures. Electromagnetic closures may be configured in numerous ways.In an embodiment, an electromagnetic closure may include a plug that isconfigured to eliminate flow through a port 144. The plug may beoperably coupled to a spring such that the plug is forced into a port144 by the spring. The plug may be removed from the port 144 throughapplication of a magnetic field to the plug through use of anelectromagnet. Accordingly, flow through the exit port may be controlledthrough application of a magnetic field to the plug. In an embodiment,an electromagnetic closure for an exit port may include a hatchwaymechanism wherein a door that covers the exit port may be opened throughapplication of a magnetic field to the door. In an embodiment, one ormore ports 144 may be configured to facilitate exit of one or moreappetite suppressants 162 from a hunger control delivery reservoir 128to the subject.

In an embodiment, one or more ports 144 may include one or morepiezoelectric closures. In an embodiment, one or more piezoelectricclosures may be configured such that application of an electric currentto one or more piezoelectric materials within the closure causes the oneor more piezoelectric materials to distort and open a port 144. In anembodiment, one or more piezoelectric closures may be configured suchthat application of an electric current to one or more piezoelectricmaterials within the closure causes the one or more piezoelectricmaterials to distort and close a port 144. Piezoelectric valves havebeen described (e.g., Lindler and Anderson, Piezoelectric Direct DriveServovalve, SPIE Paper 4698-53, Industrial and Commercial Applicationsof Smart Structures Technologies, San Diego, March 2002), incorporatedherein by reference.

In an embodiment, one or more device housings 140 that are operablycoupled to the one or more moveable members 158 and the one or moreports 144 may include one or more reservoirs 128. In an embodiment, oneor more device housings 140 may be configured to include one or morereservoirs 128 that are positioned between one or more moveable members158 and one or more ports 144. Accordingly, movement of the one or moremoveable members 158 toward the one or more ports 144 will cause one ormore appetite suppressants 162 contained within the one or morereservoirs 128 to be extruded through the one or more ports 144.

In an embodiment, one or more device housings 140 that are operablycoupled to the one or more moveable members 158 and the one or moreports 144 may include one or more energy storage devices 134. A devicehousing 140 may be operably coupled to numerous types of energy storagedevices 134. Examples of such energy storage devices 134 include, butare not limited to, batteries (e.g., thin-film batteries), capacitors,electromagnetic receivers, and the like.

In an embodiment, one or more device housings 140 that are operablycoupled to the one or more moveable members 158 and the one or moreports 144 may include one or more transmitters 126. A device housing 140may include numerous types of transmitters 126. Examples of suchtransmitters 126 include, but are not limited to, transmitters thattransmit one or more analog signals, digital signals, acoustic signals,optical signals, radio signals, wireless signals, hardwired signals,infrared signals, ultrasonic signals, and the like.

In an embodiment, one or more device housings 140 that are operablycoupled to the one or more moveable members 158 and the one or moreports 144 may include one or more ratchet members 109. In an embodiment,one or more device housings 140 may be configured to include one or moreratchet members 109 that are operably coupled with one or more moveablemembers 158. In an embodiment, the one or more ratchet members 109 maybe configured to move the one or more operably coupled moveable members158 toward one or more ports 144. In an embodiment, the device housing140 may be configured to include one or more reservoirs 142 that arepositioned between the one or more ports 144 and the one or moremoveable members 158. Accordingly, in an embodiment, movement of the oneor more ratchet members 109 by one or more motors 156 will move the oneor more moveable members 158 toward the one or more ports 144 andfacilitate extrusion of one or more appetite suppressants 162 that arecontained within the one or more reservoirs 128.

As illustrated in FIG. 12, in an embodiment of thestomach-volume-reducing device 1200, module 1210 includes an appetitesuppressant reservoir and optionally fluid for activating theenvironmental condition responsive particles, if present. In anembodiment, module 1220, the device includes a transmitter or, module1230, a receiver, or module 1240, an energy storage device.

As illustrated in FIG. 13, a system 1300 includes means 1305 foroperating at least one motor operably coupled to at least one actuatablemechanical truss; 1310 means for operating one or more appetitesuppressant delivery control units that are operably coupled to the atleast one motor and that are responsive to one or more signals receivedfrom one or more sensors of a stomach-volume reducing device, and in oneembodiment 1320, means for operating one or more ports.

As illustrated in FIG. 14, in an embodiment 1400 of thestomach-volume-reducing device, the device includes one or more motors1410, one or more moveable members that are operably associated with theone or more motors 1420, one or more hunger control delivery units thatare operably associated with the one or more motors 1430, one or moreports 1440. In an embodiment, 1402, one or more ports include one ormore shape memory closures. In an embodiment 1404, one or more portsinclude one or more slit valves. In an embodiment 1406, one or moreports include one or more electromagnetic closures. In an embodiment1408, one or more ports include one or more piezoelectric closures. Inan embodiment 1450, one or more device housings are operably associatedwith the one or more moveable members and the one or more ports.

FIG. 15 illustrates a partial view of a system 1500 that includes acomputer program 1504 for executing a computer process on a computingdevice 1503. An embodiment of system 1500 is provided using asignal-bearing medium 1502 bearing one or more instructions foroperating one or more motors 156; one or more instructions for operatingone or more hunger control delivery units 146 that are operably coupledto the one or more motors 156 and that are responsive to one or moresignals received from one or more implanted sensors 102; and one or moreinstructions for operating one or more ports 144. The one or moreinstructions may be, for example, computer executable and/orlogic-implemented instructions. In an embodiment, the signal-bearingmedium 1502 may include a computer-readable medium 1506. In anembodiment, the signal-bearing medium 1502 may include a recordablemedium 1508. In an embodiment, the signal-bearing medium 1502 mayinclude a communications medium 1510.

FIG. 16 illustrates a partial view of a system 1600 that includes acomputer program 1604 for executing a computer process on a computingdevice 1603. An embodiment of system 1600 is provided using asignal-bearing medium 1602 bearing one or more instructions foroperating one or more motors 156; one or more instructions for operatingone or more hunger control delivery units 146 that are operably coupledto the one or more motors 156 and that are responsive to one or moresignals received from one or more implanted sensors 102; one or moreinstructions for operating one or more ports 144; and one or moreinstructions for operating one or more device housings that are operablycoupled to the one or more moveable members and the one or more ports.The one or more instructions may be, for example, computer executableand/or logic-implemented instructions. In an embodiment, thesignal-bearing medium 1602 may include a computer-readable medium 1606.In an embodiment, the signal-bearing medium 1602 may include arecordable medium 1608. In an embodiment, the signal-bearing medium 1602may include a communications medium 1610.

FIGS. 17A and 17B illustrate embodiments of a hunger control deliveryreservoir 128 that includes a piezoelectric linear motor 156 that isoperably coupled to a moveable member 158 through a ratcheted member2500. The hunger control delivery reservoir 128 includes a devicehousing 140, a hunger control delivery unit 146, one or more appetitesuppressants 162, and a port 144. The moveable member 158 is illustratedin an advanced position relative to the position of the moveable member158 as illustrated in FIG. 17A.

FIG. 18A illustrates an embodiment of a hunger control deliveryreservoir 128 that includes a piezoelectric linear motor 156 that isoperably coupled to a moveable member 158 through a ratcheted member2500. The hunger control delivery reservoir 128 includes a devicehousing 140, a hunger control delivery unit 146, one or more appetitesuppressants 162, a port 144, and moveable member retainers 2600.

FIG. 18B illustrates an embodiment of a hunger control deliveryreservoir 128 that includes a piezoelectric linear motor 156 that isoperably coupled to a moveable member 158 through a ratcheted member2500. The hunger control delivery reservoir 128 includes a devicehousing 140, a hunger control delivery unit 146, one or more appetitesuppressants 162, a port 144, and moveable member retainers 2600. Themoveable member 158 is illustrated in an advanced position relative tothe position of the moveable member 158 as illustrated in FIG. 26A.

FIG. 19A illustrates an embodiment of a hunger control deliveryreservoir 128 that includes an osmotic motor 156 that facilitatesmovement of a moveable member 158 through introduction of solute intothe osmotic motor 156. The hunger control delivery reservoir 128includes a device housing 140, a hunger control delivery unit 146, oneor more appetite suppressants 162, an electromagnetic exit port 2000that is shown in the closed position, and an electromagnetic entry port2700 that is shown in the closed position.

FIG. 19B illustrates an embodiment of a stomach volume reducing devicethat optionally includes a hunger control delivery reservoir 128 andincluding an osmotic motor 156 that facilitates movement of a moveablemember 158 through introduction of solute into the osmotic motor 156.The hunger control delivery reservoir 128 includes a reservoir housing140, a hunger control delivery unit 146, one or more appetitesuppressants 162, an electromagnetic exit port 2000 that is shown in theopen position, and an electromagnetic entry port 2700 that is shown inthe open position. The moveable member 158 is illustrated in an advancedposition relative to the position of the moveable member 158 asillustrated in FIG. 27A.

FIG. 20A illustrates an embodiment of a hunger control deliveryreservoir 128 that includes an osmotic motor 156 that facilitatesmovement of a moveable member 158 through introduction of solute intothe osmotic motor 156. The hunger control delivery reservoir 128includes a device housing 140, hunger control delivery units 146, one ormore appetite suppressants 162, an exit port 2800 made from a shapememory material that is shown in the closed position, and an entry port2802 made from a shape memory material that is shown in the closedposition.

FIG. 21A illustrates an embodiment of a hunger control deliveryreservoir 128 that includes an assembly of subject hunger controldelivery reservoirs 128. Each hunger control delivery reservoir 128includes an osmotic motor 156 that facilitates movement of a moveablemember 158 through introduction of solute into the osmotic motor 156.Each hunger control delivery reservoir 128 includes a device housing140, hunger control delivery units 146, one or more appetitesuppressants 162, an exit port 2800 made from a shape memory materialthat is shown in the closed position, and an entry port 2802 made from ashape memory material that is shown in the closed position.

FIG. 21B illustrates an embodiment of a hunger control deliveryreservoir 128 that includes an assembly of subject hunger controldelivery reservoirs 128. Each hunger control delivery reservoir 128includes an osmotic motor 156 that facilitates movement of a moveablemember 158 through introduction of solute into the osmotic motor 156.Each hunger control delivery reservoir 128 includes a device housing140, hunger control delivery units 146, one or more appetitesuppressants 162, an exit port 2800 made from a shape memory materialthat is shown in the open position, and an entry port 2802 made from ashape memory material that is shown in the open position. The moveablemembers 158 are shown in an advanced position relative to their positionas illustrated in FIG. 29A.

FIG. 22A illustrates a side-view of an embodiment of sensor 102 thatincludes a sensor control unit 104, and a sensor housing 184 thatincludes selectively accessible sections 112 that are covered with asacrificial layer 3000 and which enclose sensor detectors 114. All ofthe selectively accessible sections 112 are shown as being sequesteredfrom the outside environment.

FIG. 22B illustrates a side-view of an embodiment of sensor 102 thatincludes a sensor control unit 104, and a sensor housing 184 thatincludes selectively accessible sections 112 that are covered with asacrificial layer 3000 and which enclose sensor detectors 114. Thesacrificial layer 3000 is shown as having been removed from three of theselectively accessible sections 112 of the sensor 102 to expose threesensor detectors 114 to the outside environment.

FIG. 23A illustrates a side-view of an embodiment of sensor 102 thatincludes a sensor control unit 104, and a sensor housing 184 thatincludes selectively accessible sections 112 that are covered with ashape memory material 3100 and which enclose sensor detectors 114. Allof the selectively accessible sections 112 are shown as beingsequestered from the outside environment.

FIG. 23B illustrates a side-view of an embodiment of sensor 102 thatincludes a sensor control unit 104, and a sensor housing 184 thatincludes selectively accessible sections 112 that are covered with ashape memory material 3100 and which enclose sensor detectors 114. Theshape memory material 3100 covering two of the selectively accessiblesections 112 is shown as having been reshaped to expose two sensordetectors 114 to the outside environment.

FIG. 23C illustrates a top-view of an embodiment of sensor 102 thatincludes a sensor control unit 104, and a sensor housing 184 thatincludes selectively accessible sections 112 and which enclose sensordetectors 114.

As illustrated in FIG. 24, a system 2400, includes circuitry 2402configured to operate 2404 at least one stomach-volume-reducing device;the stomach-volume-reducing device including a reversibly responsiveexpandable housing encasing at least one intelligent responsive matrixthat is responsive to at least one environmental condition in thestomach of a subject; at least one port; and at least one controllablemicropump or controllable valve operably connected to the at least oneport. In an embodiment 2406, the device further comprises a timer or asensor. In an embodiment 2408, the device is programmable for expansionat different rates or different levels at different time points. In anembodiment 2410, the device includes a transmitter. In an embodiment2412, the device includes a memory module. In an embodiment 2414, thedevice includes an energy storage device. In an embodiment 2416, thedevice includes one or more hunger control delivery units.

As illustrated in FIG. 25, in an embodiment, the stomach-volume-reducingdevice 2500 includes multiple layers of biodegradable materials 2510. Inan embodiment, the device housing includes a reversibly responsiveexpandable device housing 2520 optionally including or encasing at leastone intelligent responsive matrix 2530. In an embodiment, at least oneof the biodegradable materials 2510 includes a mesh 2540. In anembodiment, the device 2500 includes at least one energy storage device2550, sensor 2560, port 144, transmitter 2570, receiver 2580, orcontrollable valve or pump 2590.

As illustrated in FIG. 26, in an embodiment a system 2600 includescircuitry configured 2602 to operate 2604 at least onestomach-volume-reducing device; the stomach-volume-reducing deviceincluding a reversibly responsive expandable device housing includingmultiple layers of biodegradable materials, at least one port; and oneor more intelligent responsive matrices that are responsive to at leastone environmental condition in the stomach of a subject; optionally 2606one sensor or timer, 2610 transmitter, 2612 memory module, 2614 energystorage device, or 2616 one or more hunger control delivery units. In anembodiment, 2608 the device is programmable for expansion at differentrates or different levels at different time points.

As illustrated in FIG. 27, in an embodiment a system 2700 includescircuitry 2702 configured to operate 2705 at least onestomach-volume-reducing device, the device including a reversiblyresponsive expandable device housing, at least one motor, at least oneactuatable mechanical member operably coupled to each of the at leastone motor and the housing, optionally including one or more hungercontrol delivery units operably coupled to the at least one motor andresponsive to one or more signals received from one or more sensors of astomach-volume-reducing device. In an embodiment 2710 the deviceincludes a transmitter. In an embodiment, the device includes at leastone of a memory module 2712, or an energy storage device 2714.

As illustrated in FIG. 28, in an embodiment, a system 2800 comprises2802 circuitry configured to operate 2804 at least onestomach-volume-reducing device, including a reversibly responsiveexpandable device housing configured to primarily reside in the stomachof a subject; at least one member motor, at least one controllableratchet member or controllable extendable ladder member operably coupledto each of the at least one member motor and the housing and at leastone controllable ratchet member or controllable extendable laddermember; and at least one controller operably coupled to the at least onemotor and configured to increase or decrease the length of thecontrollable ratchet member or extendable ladder member of thestomach-volume-reducing device. In an embodiment, the device includes atleast one of a transmitter 2810, memory module 2812, energy storagedevice 2814, or one or more hunger control delivery units 2816.

As illustrated in FIG. 29, in an embodiment, a system 2900 comprisescircuitry 2902 configured to operate 2904 at least onestomach-volume-reducing device including a reversibly responsiveexpandable device housing configured to attach to a gastric wall of asubject, at least one actuatable mechanical member; at least one motoroperably coupled to the at least one actuatable mechanical member; atleast one sensor operably coupled to the at least one motor andconfigured to detect one or more electrical signals originating from asubject; one or more motors; and at least one sensor. In an embodiment,the device includes 2906 a timer. In an embodiment 2908 the device isprogrammable for expansion at different rates or different levels atdifferent time points. In an embodiment, the device includes 2910 atransmitter, or 2912 a memory module. In an embodiment, the deviceincludes an 2914 energy storage device, or 2916 one or more hungercontrol delivery units.

As illustrated in FIG. 30, in an embodiment 3000, a system includescircuitry 3002 configured to operate 3004 at least onestomach-volume-reducing device including reversibly responsiveexpandable device housing including at least one intelligent responsivematrix, at least one port; and at least one controllable micropump orcontrollable valve operably connected to the at least one port. In anembodiment, the device further comprises 3006 a timer or sensor. In anembodiment 3008 the device is programmable for expansion at differentrates or different levels at different time points. In an embodiment,the device includes a transmitter 3010. In an embodiment, the deviceincludes a memory module 3012. In an embodiment, the device includes anenergy storage device 3014. In an embodiment, the device includes one ormore hunger control delivery units 3016.

As illustrated in FIG. 31, in an embodiment 3100, a system comprises asignal-bearing medium 3102 bearing 3104 one or more instructions foroperating at least one motor operably coupled to at least to oneactuatable mechanical member; and one or more instructions for operatingone or more appetite suppressant delivery control units that areoperably coupled to the at least one motor and that are responsive toone or more signals received from one or more sensors of astomach-volume-reducing device. In an embodiment 3106, the devicefurther includes at least one timer or sensor. In an embodiment 3108,the device is programmable for expansion at different rates or differentlevels at different time points. In an embodiment, the device includes3110 a transmitter. In an embodiment, the device includes 3112 a memorymodule. In an embodiment, the device includes 3114 an energy storagedevice. In an embodiment 3116 the device includes one or more hungercontrol delivery units.

All of the above U.S. patents, U.S. patent application publications,U.S. patent applications, foreign patents, foreign patent applicationsand non-patent publications referred to in this specification and/orlisted in any Application Data Sheet, are incorporated herein byreference, to the extent not inconsistent herewith.

Those having skill in the art will recognize that the state of the arthas progressed to the point where there is little distinction leftbetween hardware, software, and/or firmware implementations of aspectsof systems; the use of hardware, software, and/or firmware is generally(but not always, in that in certain contexts the choice between hardwareand software can become significant) a design choice representing costvs. efficiency tradeoffs. Those having skill in the art will appreciatethat there are various vehicles by which processes and/or systems and/orother technologies described herein can be effected (e.g., hardware,software, and/or firmware), and that the preferred vehicle will varywith the context in which the processes and/or systems and/or othertechnologies are deployed. For example, if an implementer determinesthat speed and accuracy are paramount, the implementer may opt for amainly hardware and/or firmware vehicle; alternatively, if flexibilityis paramount, the implementer may opt for a mainly softwareimplementation; or, yet again alternatively, the implementer may opt forsome combination of hardware, software, and/or firmware. Hence, thereare several possible vehicles by which the processes and/or devicesand/or other technologies described herein may be effected, none ofwhich is inherently superior to the other in that any vehicle to beutilized is a choice dependent upon the context in which the vehiclewill be deployed and the specific concerns (e.g., speed, flexibility, orpredictability) of the implementer, any of which may vary. Those skilledin the art will recognize that optical aspects of implementations willtypically employ optically-oriented hardware, software, and or firmware.

In some implementations described herein, logic and similarimplementations may include software or other control structuressuitable to operation. Electronic circuitry, for example, may manifestone or more paths of electrical current constructed and arranged toimplement various logic functions as described herein. In someimplementations, one or more media are configured to bear adevice-detectable implementation if such media hold or transmit aspecial-purpose device instruction set operable to perform as describedherein. In some variants, for example, this may manifest as an update orother modification of existing software or firmware, or of gate arraysor other programmable hardware, such as by performing a reception of ora transmission of one or more instructions in relation to one or moreoperations described herein. Alternatively or additionally, in somevariants, an implementation may include special-purpose hardware,software, firmware components, and/or general-purpose componentsexecuting or otherwise invoking special-purpose components.Specifications or other implementations may be transmitted by one ormore instances of tangible transmission media as described herein,optionally by packet transmission or otherwise by passing throughdistributed media at various times.

Alternatively or additionally, implementations may include executing aspecial-purpose instruction sequence or otherwise invoking circuitry forenabling, triggering, coordinating, requesting, or otherwise causing oneor more occurrences of any functional operations described above. Insome variants, operational or other logical descriptions herein may beexpressed directly as source code and compiled or otherwise invoked asan executable instruction sequence. In some contexts, for example, C++or other code sequences can be compiled directly or otherwiseimplemented in high-level descriptor languages (e.g., alogic-synthesizable language, a hardware description language, ahardware design simulation, and/or other such similar mode(s) ofexpression). Alternatively or additionally, some or all of the logicalexpression may be manifested as a Verilog-type hardware description orother circuitry model before physical implementation in hardware,especially for basic operations or timing-critical applications. Thoseskilled in the art will recognize how to obtain, configure, and optimizesuitable transmission or computational elements, material supplies,actuators, or other common structures in light of these teachings.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, or examples can be implemented,subjectly and/or collectively, by a wide range of hardware, software,firmware, or virtually any combination thereof. In one embodiment,several portions of the subject matter described herein may beimplemented via Application Specific Integrated Circuits (ASICs), FieldProgrammable Gate Arrays (FPGAs), digital signal processors (DSPs), orother integrated formats. However, those skilled in the art willrecognize that some aspects of the embodiments disclosed herein, inwhole or in part, can be equivalently implemented in integratedcircuits, as one or more computer programs running on one or morecomputers (e.g., as one or more programs running on one or more computersystems), as one or more programs running on one or more processors(e.g., as one or more programs running on one or more microprocessors),as firmware, or as virtually any combination thereof, and that designingthe circuitry and/or writing the code for the software and or firmwarewould be well within the skill of one of skill in the art in light ofthis disclosure. In addition, those skilled in the art will appreciatethat the mechanisms of the subject matter described herein are capableof being distributed as a program product in a variety of forms, andthat an illustrative embodiment of the subject matter described hereinapplies regardless of the particular type of signal bearing medium usedto actually carry out the distribution. Examples of a signal bearingmedium include, but are not limited to, the following: a recordable typemedium such as a floppy disk, a hard disk drive, a Compact Disc (CD), aDigital Video Disk (DVD), a digital tape, a computer memory, etc.; and atransmission type medium such as a digital and/or an analogcommunication medium (e.g., a fiber optic cable, a waveguide, a wiredcommunications link, a wireless communication link (e.g., transmitter,receiver, transmission logic, reception logic, etc.), etc.).

In a general sense, those skilled in the art will recognize that thevarious embodiments described herein can be implemented, subjectlyand/or collectively, by various types of electro-mechanical systemshaving a wide range of electrical components such as hardware, software,firmware, and/or virtually any combination thereof; and a wide range ofcomponents that may impart mechanical force or motion such as rigidbodies, spring or torsional bodies, hydraulics, electro-magneticallyactuated devices, and/or virtually any combination thereof.Consequently, as used herein “electro-mechanical system” includes, butis not limited to, electrical circuitry operably coupled with atransducer (e.g., an actuator, a motor, a piezoelectric crystal, a MicroElectro Mechanical System (MEMS), etc.), electrical circuitry having atleast one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a microprocessor configured by a computer program which at leastpartially carries out processes and/or devices described herein),electrical circuitry forming a memory device (e.g., forms of memory(e.g., random access, flash, read only, etc.)), electrical circuitryforming a communications device (e.g., a modem, communications switch,optical-electrical equipment, etc.), and/or any non-electrical analogthereto, such as optical or other analogs. Those skilled in the art willalso appreciate that examples of electro-mechanical systems include butare not limited to a variety of consumer electronics systems, medicaldevices, as well as other systems such as motorized transport systems,factory automation systems, security systems, and/orcommunication/computing systems. Those skilled in the art will recognizethat electro-mechanical as used herein is not necessarily limited to asystem that has both electrical and mechanical actuation except ascontext may dictate otherwise.

In a general sense, those skilled in the art will recognize that thevarious aspects described herein which can be implemented, subjectlyand/or collectively, by a wide range of hardware, software, firmware,and/or any combination thereof can be viewed as being composed ofvarious types of “electrical circuitry.” Consequently, as used herein“electrical circuitry” includes, but is not limited to, electricalcircuitry having at least one discrete electrical circuit, electricalcircuitry having at least one integrated circuit, electrical circuitryhaving at least one application specific integrated circuit, electricalcircuitry forming a general purpose computing device configured by acomputer program (e.g., a general purpose computer configured by acomputer program which at least partially carries out processes and/ordevices described herein, or a microprocessor configured by a computerprogram which at least partially carries out processes and/or devicesdescribed herein), electrical circuitry forming a memory device (e.g.,forms of memory (e.g., random access, flash, read only, etc.)), and/orelectrical circuitry forming a communications device (e.g., a modem,communications switch, optical-electrical equipment, etc.). Those havingskill in the art will recognize that the subject matter described hereinmay be implemented in an analog or digital fashion or some combinationthereof.

Those skilled in the art will recognize that at least a portion of thedevices and/or processes described herein can be integrated into animage processing system. Those having skill in the art will recognizethat a typical image processing system generally includes one or more ofa system unit housing, a video display device, memory such as volatileor non-volatile memory, processors such as microprocessors or digitalsignal processors, computational entities such as operating systems,drivers, applications programs, one or more interaction devices (e.g., atouch pad, a touch screen, an antenna, etc.), control systems includingfeedback loops and control motors (e.g., feedback for sensing lensposition and/or velocity; control motors for moving/distorting lenses togive desired focuses). An image processing system may be implementedutilizing suitable commercially available components, such as thosetypically found in digital still systems and/or digital motion systems.

Those skilled in the art will recognize that at least a portion of thedevices and/or processes described herein can be integrated into a dataprocessing system. Those having skill in the art will recognize that adata processing system generally includes one or more of a system unithousing, a video display device, memory such as volatile or non-volatilememory, processors such as microprocessors or digital signal processors,computational entities such as operating systems, drivers, graphicaluser interfaces, and applications programs, one or more interactiondevices (e.g., a touch pad, a touch screen, an antenna, etc.), and/orcontrol systems including feedback loops and control motors (e.g.,feedback for sensing position and/or velocity; control motors for movingand/or adjusting components and/or quantities). A data processing systemmay be implemented utilizing suitable commercially available components,such as those typically found in data computing/communication and/ornetwork computing/communication systems.

Those skilled in the art will recognize that at least a portion of thedevices and/or processes described herein can be integrated into a motesystem. Those having skill in the art will recognize that a typical motesystem generally includes one or more memories such as volatile ornon-volatile memories, processors such as microprocessors or digitalsignal processors, computational entities such as operating systems,user interfaces, drivers, sensors, actuators, applications programs, oneor more interaction devices (e.g., an antenna USB ports, acoustic ports,etc.), control systems including feedback loops and control motors(e.g., feedback for sensing or estimating position and/or velocity;control motors for moving and/or adjusting components and/orquantities). A mote system may be implemented utilizing suitablecomponents, such as those found in mote computing/communication systems.Specific examples of such components entail such as Intel Corporation'sand/or Crossbow Corporation's mote components and supporting hardware,software, and/or firmware.

Those skilled in the art will recognize that it is common within the artto implement devices and/or processes and/or systems, and thereafter useengineering and/or other practices to integrate such implemented devicesand/or processes and/or systems into more comprehensive devices and/orprocesses and/or systems. That is, at least a portion of the devicesand/or processes and/or systems described herein can be integrated intoother devices and/or processes and/or systems via a reasonable amount ofexperimentation. Those having skill in the art will recognize thatexamples of such other devices and/or processes and/or systems mightinclude—as appropriate to context and application—all or part of devicesand/or processes and/or systems of (a) an air conveyance (e.g., anairplane, rocket, helicopter, etc.), (b) a ground conveyance (e.g., acar, truck, locomotive, tank, armored personnel carrier, etc.), (c) abuilding (e.g., a home, warehouse, office, etc.), (d) an appliance(e.g., a refrigerator, a washing machine, a dryer, etc.), (e) acommunications system (e.g., a networked system, a telephone system, aVoice over IP system, etc.), (f) a business entity (e.g., an InternetService Provider (ISP) entity such as Comcast Cable, Qwest, SouthwesternBell, etc.), or (g) a wired/wireless services entity (e.g., Sprint,Cingular, Nextel, etc.), etc.

In certain cases, use of a system or method may occur in a territoryeven if components are located outside the territory. For example, in adistributed computing context, use of a distributed computing system mayoccur in a territory even though parts of the system may be locatedoutside of the territory (e.g., relay, server, processor, signal-bearingmedium, transmitting computer, receiving computer, etc. located outsidethe territory). A sale of a system or method may likewise occur in aterritory even if components of the system or method are located and/orused outside the territory.

Further, implementation of at least part of a system for performing amethod in one territory does not preclude use of the system in anotherterritory.

One skilled in the art will recognize that the herein describedcomponents (e.g., operations), devices, objects, and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are contemplated.Consequently, as used herein, the specific exemplars set forth and theaccompanying discussion are intended to be representative of their moregeneral classes. In general, use of any specific exemplar is intended tobe representative of its class, and the non-inclusion of specificcomponents (e.g., operations), devices, and objects should not be takenlimiting.

Those skilled in the art will appreciate that a user may berepresentative of a human user, a robotic user (e.g., computationalentity), and/or substantially any combination thereof (e.g., a user maybe assisted by one or more robotic agents) unless context dictatesotherwise.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures may beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “operably coupled to” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected”, or“operably coupled”, to each other to achieve the desired functionality,and any two components capable-of being so associated can also be viewedas being “operably couplable”, to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

In some instances, one or more components may be referred to herein as“configured to,” “configurable to,” “operable/operative to,”“adapted/adaptable,” “able to,” “conformable/conformed to,” etc. Thoseskilled in the art will recognize that “configured to” can generallyencompass active-state components and/or inactive-state componentsand/or standby-state components, unless context requires otherwise.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from the subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of the subject matter described herein.It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be typicallyunderstood to include the possibilities of “A” or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flows are presented in asequence(s), it should be understood that the various operations may beperformed in other orders than those which are illustrated, or may beperformed concurrently. Examples of such alternate orderings may includeoverlapping, interleaved, interrupted, reordered, incremental,preparatory, supplemental, simultaneous, reverse, or other variantorderings, unless context dictates otherwise. Furthermore, terms like“responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

Various non-limiting embodiments are described herein as PropheticExamples.

Prophetic Example 1 A pH-Responsive Intragastric Device to InduceSatiety

A pH-responsive stomach filling device is constructed from biodegradablepolymer and a pH-sensitive hydrogel. The device is constructed with anexpandable polymer envelope encasing hydrogel particles which expandunder acidic conditions and contract under neutral conditions. ApH-responsive hydrogel synthesized with ionizable monomers,2-dimethylaminoethyl methacrylate (DMAEMA) and N-isopropylacrylamide(NIPAM) is described (see e.g., Zhang et al., Polymer 50: 2516-2525,2009, which is incorporated herein by reference). The hydrogel absorbswater and swells in response to acidic conditions, e.g., pH≦4, andcollapses and frees water when the pH rises, e.g., pH≧7.5 or above. Thehydrogel may swell approximately tenfold when the pH is decreased fromapproximately pH=8 to pH=4 at 37° C. Superporous hydrogels that displayrapid (approximately 5 minutes or less) and reversible pH-dependentswelling may be synthesized using a freeze drying/gas blowing techniqueand glyoxal as a crosslinking agent. Methods and compositions to createreversibly swelling superporous hydrogels are described (see e.g., Guptaand Shivakumar, DARU 18(3): 200-210, 2010, which is incorporated hereinby reference).

A flexible, long-lasting biodegradable envelope is fabricated to containthe pH-responsive hydrogel. In an embodiment, the long-lastingbiodegradable envelope is time-dependent. The envelopes may becylindrical and approximately 3 cm in length with a radius ofapproximately 1 cm. The envelopes contain a micropump and valves tocontrol the flow of fluid in and out of the envelope. The flexibleenvelopes are constructed from a biodegradable material, for example acopolymer of lactide, glycolide, and caprolactone (see e.g., Bertleff etal., J. Soc. Lap. Surg. 13: 550-554, 2009, which is incorporated hereinby reference), and contain a micropump and valves to allow pumping offluid in and out of the envelope. A piezoelectric micropump isincorporated in the envelopes (e.g., Nanopump™ available from DebiotechS.A., Lausanne, Switzerland; see Tech Sheet: Implantable Nanopump™,which is incorporated herein by reference), and the envelopes are filledwith approximately 9 cm³ hydrogel particles. The micropump is controlledby circuitry and a battery integrated onto the Nanopump™ chip, andwireless signaling allows turning the pump on and off as required. Thecompleted envelopes are sealed with biocompatible cyanoacrylate glue(Glubran 2 available from GEM, Viareggio, Italy).

To avoid gastric bypass surgery or other invasive procedures and yetreduce food consumption, a weight loss patient ingests 11 to 12envelopes containing pH-responsive hydrogel. When the patient desires toincrease his feeling of satiety, e.g., prior to a meal he ingestsapproximately 250 to 700 mL, up to 1000 mL acidic water, depending ondegree of satiety desired. A wireless device is used to remotely actuatethe micropumps on the envelopes to pump acidic stomach fluid into thelumen of the envelopes. After as long as 80 minutes, the pumps areturned off and the valves are closed. The hydrogel will swell in acidicstomach fluid (e.g., approximate pH=3) to as much as 10 times itsoriginal volume (i.e., approximately 90 mL per envelope). The totalvolume of the envelopes may be approximately 250 mL to 1 liter andlikely to occupy approximately 20% to 90% of the available space in thestomach. In an embodiment, approximately 40% of the available space inthe stomach is occupied by the stomach volume reducing device.

To eliminate discomfort from the swollen envelopes or to make room for ameal, the obese patient can reduce the volume of the envelopes byintroducing a buffer solution at approximately pH=8 into the envelopes.Approximately 250 to 1000 mL of a sodium bicarbonate buffer solution atapproximately pH≧8.0 is ingested by the patient and the micropumps onthe envelopes are activated remotely to pump bicarbonate buffer solutioninto the envelopes. Neutralization of the hydrogel will free water fromthe hydrogel and allow the hydrogel to shrink. The freed water is pumpedout of the envelopes, and they may contract to approximately 1/10 thevolume, i.e., from about 90 mL to about 9 mL. The envelopes may shrinkto cylinders approximately 3 cm long and 2 cm in diameter, a size thatis likely to be retained in the stomach during peristalsis where amaximum particle size of approximately 2 mm is allowed passage throughthe pyloric valve. Alternatively, an intermediate degree ofswelling/shrinking may be induced by consumption of a buffer solution atan intermediate pH, for example at pH=7 the swollen hydrogel maycontract to approximately 70% of its volume at pH=4 (see e.g., Zhang etal., Ibid.). To reestablish satiety and stomach filling the patient mayinduce the envelopes in his stomach to swell again by ingesting acidicwater and activating the micropump and valves on the envelopes. Repeatedcycles of swelling and shrinking the envelopes may be induced byingesting appropriate buffer solutions and actuating micropumps andvalves to exchange buffer solutions between the stomach and envelopes.

The envelopes and the hydrogel particles they contain are biodegradableto guard against gastric obstruction and to allow periodic adjustment ofthe number of envelopes residing in the stomach. The envelopes areconstructed of a biodegradable polymer, for example,lactide-glycolide-caprolactone (available from LGC, Polyganics, B. V.Groningen, Netherlands), and may undergo hydrolysis and degradation overa period of approximately 5 weeks (see e.g., Bertleff et al., Ibid.).Methods and compositions to make biodegradable polymers that degrade inweeks, months or years are described (see e.g., U.S. Pat. No. 7,919,112B2 issued to Pathak et al. on Apr. 5, 2011, which is incorporated hereinby reference). For example, a polymer envelope may be produced thatdegrades in 6 months following ingestion. Degradation of the envelopereleases its hydrogel particles into the stomach fluid and allows themechanical and chemical digestion of the hydrogel particles as well asthe envelope. Degradation and digestion of the envelope and hydrogelparticles facilitates their passage through the pyloric valve andultimately excretion through the colon.

Prophetic Example 2 A Glucose-Responsive, pH-Sensitive AdherentIntragastric Device to Reduce Food Ingestion

A moderately obese subject with a Body Mass Index of approximately 30,wishes to reduce his food intake without undergoing an invasiveprocedure. He is orally administered a stomach filling device whichresides in the stomach. The device responds to a first chemical signalprovided when the subject desires a feeling of satiety, for example ahigh level of glucose. The responsive device swells in the low pHenvironment of the stomach and thereby reduces the volume of thestomach. After a time, the glucose is catalytically degraded by enzymesin the responsive gel, where the oxygen-rich product aids in swellingproperties. The device remains in a swollen state until the subject orhis caregiver decides to reduce the volume of the device, whereupon asecond signal, a buffer at pH=7.5, is given orally to cause the deviceto shrink. The device, enclosed in an envelope with valves and aminipump, may be swollen and shrunk multiple cycles, and may be swollenor shrunk to intermediate sizes, e.g., to 50% of maximum size.

A chemically responsive hydrogel is used to construct the stomachfilling device, for example a glucose-responsive, pH-sensitive hydrogelthat is activated by glucose and swells in low pH conditions.Preparation of a glucose-responsive, pH-sensitive hydrogel constructedhas been described (see e.g., Podual et al., Polymer 41: 3975-3983,2000, which is incorporated herein by reference). Briefly, two monomers,diethylaminoethyl methacrylate (DEAEM) and poly(ethyleneglycol)monomethacrylate (PEGMA) are combined with a crosslinking agent,triethylene glycol dimethacrylate (TEGDMA), then a solution of thefunctionalized enzymes glucose oxidase and catalase, and containing thebinding agent acryloyl chloride, is added to the comonomer mixture. Theresulting copolymer is dried in a vacuum oven and enveloped in elastic,biodegradable polymeric envelopes.

An elastic biodegradable envelope is fabricated to contain theglucose-responsive, pH-sensitive hydrogel and isolate it from gastricfluid. Each envelope may be cylindrical and approximately 3 cm in lengthwith a radius of approximately 1 cm. The envelopes each contain amicropump and valves to control the flow of fluid in and out of theenvelope. The flexible envelopes are constructed from a time-dependentbiodegradable material, for example, a copolymer of lactide, glycolideand caprolactone (see e.g., Bertleff et al., J. Soc. Lap. Surg. 13:550-554, 2009, which is incorporated herein by reference). To promoteretention in the stomach, the envelope also contains chitosan, acationic polysaccharide, which adheres to the mucosal surface. Methodsand compositions to incorporate chitosan in polymers are described (seee.g., U.S. Pat. No. 7,919,293 B2 issued to Sung et al. on Apr. 5, 2011which is incorporated herein by reference). The envelopes are filledwith approximately 9 cm³ hydrogel particles, and they contain amicropump and valves to allow pumping fluid in and out of the envelope.A piezoelectric micropump is incorporated in the envelopes (e.g.,Nanopump™ available from Debiotech S.A., Lausanne, Switzerland: see TechSheet: Implantable Nanopump™, which is incorporated herein byreference). The micropump is controlled by circuitry and a batteryintegrated onto the Nanopump™ chip, and wireless signaling allowsturning the pump on and off as required. The completed envelopes aresealed with biocompatible cyanoacrylate glue (Glubran 2 available fromGEM, Viareggio, Italy).

To induce satiety and reduce food consumption, the overweight subjectingests 11 to 12 envelopes containing the glucose-responsive,pH-sensitive hydrogel and, prior to a meal, ingests approximately250-1000 mL, depending on desired satiety, of 0.1 M Dextrose in salineat pH=6.5. Shortly afterward (approximately 1-2 minutes later) awireless device is used to remotely actuate the optional micropumps onthe envelopes to pump the acidic buffer and stomach fluid into the lumenof the envelopes. After as long as 80 minutes the pumps are turned offand the valves are closed. The hydrogel, in the presence of the glucose,will hydrate and swell in acidic fluid (e.g., approximate pH<7) to asmuch as 10 times its volume (i.e., approximately 90 mL per envelope).The total volume of the envelopes may be approximately 250 mL-1 literand likely to occupy approximately 20% to 90% of the available space inthe stomach. The envelopes may adhere to the stomach mucosa by virtue ofthe chitosan they contain.

To remove discomfort from the swollen envelopes or to make room for ameal, the subject patient can reduce the volume of the envelopes byintroducing a buffer solution at approximately pH=7.4 into theenvelopes. Approximately 250-1000 mL of a sodium bicarbonate buffersolution at approximately pH≧7.4 is ingested by the patient. In theabsence of glucose, which has been degraded by the immobilized enzyme inthe hydrogel, neutralization of the hydrogel will free water from thehydrogel and allow the hydrogel to shrink as much as tenfold by weight(See e.g., Podual et al., Ibid.). The device may contract toapproximately 1/10 their volume, i.e., from about 90 mL to about 9 mL.The shrunken envelopes may remain adhered to the gastric mucosa throughbinding by chitosan present in the envelopes. Alternatively, anintermediate degree of swelling/shrinking may be induced by consumptionof a buffer solution at an intermediate pH, for example at pH=7, and theswollen hydrogel may contract to approximately 50% of its maximum volumeat pH=6.5 (see e.g., Podual et al., Ibid.). To reestablish satiety andstomach filling, the patient may induce the envelopes in his stomach toswell again by ingesting acidic water and activating the micropump andvalves on the envelopes. Repeated cycles of swelling and shrinking theenvelopes may be induced by ingesting various amounts of appropriatebuffer solutions and optional actuating micropumps and valves toexchange buffer solutions between the stomach and envelopes.

The envelopes and the hydrogel particles they contain are biodegradableto guard against gastric obstruction and to allow periodic adjustment ofthe number of envelopes residing in the stomach. The envelopes areconstructed of a biodegradable polymer, for example,lactide-glycolide-caprolactone (available from LGC, Polyganics, B. V.Groningen, Netherlands), and undergo hydrolysis and degradation over aperiod of approximately 5 weeks (see e.g., Bertleff et al., Ibid.).Methods and compositions to make biodegradable polymers that degrade inweeks, months or years are described (see e.g., U.S. Pat. No. 7,919,112B2 issued to Pathak et al. on Apr. 5, 2011 which is incorporated hereinby reference). For example a polymer envelope may be produced whichdegrades in 1 year following ingestion. Degradation of the envelopereleases its hydrogel particles into the stomach fluid and allows themechanical and chemical digestion of the hydrogel particles as well asthe envelope. Degradation and digestion of the envelope and hydrogelparticles facilitates their passage through the pyloric valve andultimately excretion through the colon. See FIG. 1.

For example, as already stated, FIG. 1 illustrates an embodiment inwhich a reversibly responsive expandable housing device is a polymerenvelope that is encasing glucose-responsive, pH-sensitive hydrogelparticles. A portion of the hydrogel particles or a subset of theingested envelopes may include, within the glucose-responsive,pH-sensitive hydrogel, an appetite suppressant that is released upon thegel swelling in response to the glucose and in the presence of low pH.Further, the device includes a microchip, piezoelectric pump, a port 144that may be operably associated with a sensor for sensing at least oneenvironmental condition of the subject's stomach, and one or moremicrovalves.

Prophetic Example 3 An Automatic Intragastric Device Responsive to aProvided Chemical and to External Wireless Signals

An automatic stomach filling device is implanted in the stomach of anobese patient to induce satiety and reduce food intake. A responsive,reversibly responsive expandable, stomach-filling device is attached tothe stomach wall of the patient and will potentially occupyapproximately 0.4 L to 4 L in the stomach. The device expands orcontracts in response to signals from a microsensor able to detect achemical in the stomach. The stomach filling device may also becontrolled manually using an external remote via a wireless signal. Thedevice may be expanded or contracted to occupy variable volumesrepresenting 10% to 100% of the subject's maximal stomach volume.

The intragastric device contains multiple “umbrella-like” devices thatexpand and contract by virtue of piezo-electric motors which raise orlower space-filling “umbrellas,” (e.g. mechanical members or truestretchers and ribs as in the mechanics of an umbrella). The devicescontain two ellipsoid space fillers (umbrellas) and four member rodsthat are driven by four piezo-electric motors 156. See FIG. 2. Theellipsoid umbrellas and member rods are constructed from a long-lastingbiodegradable material, for example, a copolymer of lactide, glycolideand caprolactone (see e.g., Bertleff et al., J. Soc. Lap. Surg. 13:550-554, 2009, which is incorporated herein by reference).Piezo-electric motors 2.8×2.8×6 mm with a thrust speed of approximately10 mm/sec are available from New Scale Technologies Inc., Victor, N.Y.,and are powered by 2.3 volts DC. The umbrella devices each includecontrol circuitry (e.g., a microchip), which responds to electricalsignals from chemical-detecting microsensors and actuates thepiezo-electric motors 156. Alternatively the piezoelectric motors 156are controlled manually by signaling from an external wireless remote.

The chemical-detecting microsensor is a surface acoustic wave sensorthat includes a piezoelectric layer, or piezoelectric substrate, ahydrogel located on the surface of the sensor with a molecularrecognition component within the hydrogel capable of detecting thechemical, and input and output transducer(s). The molecular recognitioncomponent is a nucleic acid analog immobilized in the hydrogel andhaving a backbone comprising phosphoramide. The probe nucleic acidanalog specifically recognizes and binds to a provided chemical that isa peptide nucleic acid. The provided chemical is ingested in a gelatincapsule together with an aqueous liquid, and the gelatin capsule quicklydissolves. Binding of the provided chemical by the probe recognitionelement alters the phase of the hydrogel, and this change is detected asa change in a property of the propagating surface acoustic wave. Thesurface acoustic wave generated within the piezoelectric layer isdetected by interdigitated electrodes and transduced by the outputtransducer into an electrical signal, which is transmitted via thecontrol circuitry to the umbrella device. A chemical-detecting surfaceacoustic wave microsensor with responsive hydrogel is described in U.S.Patent App. Pub. No. 2006/0024813, which is incorporated herein byreference.

Multiple umbrella devices are enveloped in a flexible polymer envelope,which may be fabricated from silicone. The envelope may be fabricated tofit the subject's stomach. Imaging of the stomach using magneticresonance imaging, computed tomography, or other techniques can be usedto model the subject's stomach shape and create an envelope to occupyapproximately 10% of maximal stomach volume (e.g., approximately 0.4 Lfor stomach with maximum volume of 4 L). A three-dimensional printer(available from Z Corporation, Burlington, Mass.) may be used to producea mandrel for generating the envelope. Fabrication of silicone balloonsis described (See e.g., U.S. Patent App. Pub. No. 2007/0100368 byQuijano et al., which is incorporated herein by reference).Approximately 40 umbrella devices, which occupy approximately 0.4 L inthe contracted state (see FIG. 2), are placed in the silicone envelope,and the envelope is sealed with biocompatible cyanoacrylate glue(Glubran 2 available from GEM, Viareggio, Italy).

For example, as already indicated, FIG. 2 illustrates a reversiblyresponsive expandable device housing that is, in this embodiment, anon-toxic polymer envelope encasing an actuatable mechanical member(truss rod, as noted other actuatable mechanical members can be used).As illustrated in FIG. 2, the actuatable mechanical members are moveableby at least one piezoelectric motor. In addition, the device includes amotor control chip (operably coupled to control circuitry) and anellipsoid space filler. In an embodiment, a sensor is operably coupledto at least one of the actuatable mechanical member, or the motor.

The completed intragastric device is implanted using an endoscopic tubeand a sheath to compress the device. Methods to compress stomach fillingdevices and implant them using endoscopy are described (See e.g., U.S.Patent App. Pub. No. 2007/0100368 Ibid.). The intragastric device isattached to the stomach wall using sutures introduced by endoscopicmethods. Methods and devices to suture the stomach wall are described(see e.g., Swanstrom et al. The Permanente Journal 12: 42-47, 2008,which is incorporated herein by reference). The intragastric device maybe removed by an endoscopic procedure that includes cutting the suturesto the stomach and retrieving the device using a sheath and retrievaltool (see e.g., U.S. Patent App. Pub. No. 2007/0100368 Ibid.).

To reduce food ingestion, the intragastric device expands automaticallyin response to electrical signals from the chemical-detecting sensor.See FIG. 3. For example, FIG. 3 illustrates a stomach volume reducingdevice in a collapsed state (FIG. 3A), as well as in an expanded state(FIG. 3B). For example, the chemical is ingested prior to an expectedmeal, and the chemical-detecting sensor, after detecting the chemical,transmits an electrical signal to the umbrella-like devices to actuatethe piezo-electric motors, erect the ellipsoid space fillers, and expandthe space filling device to occupy approximately 70% of the stomachvolume. The chemical-detecting sensor may also signal to reduce thespace filling volume, i.e., contract the device, when the chemical hasdissipated from the gel over time and no additional chemical isdetected, or after a predetermined time (e.g., 2-3 hours followingeating or signaling). An external remote control may be used to reduceor increase the volume of the device to variable degrees. For example,the subject may use the external remote control to respond to gastricdiscomfort or make room for a meal by reducing the volume of the device.Alternatively, the external remote may be used to increase the feelingof fullness or to fill an expanded stomach by increasing the volume ofthe device. See FIG. 2.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

What is claimed is:
 1. A device, comprising: a reversibly responsiveexpandable device housing configured to reversibly expand and contract,and wherein the reversibly responsive expandable device housing includesmultiple layers of biodegradable material, at least one port; and one ormore glucose-responsive, pH-sensitive hydrogels with at least oneappetite suppressant contained therein.
 2. The device of claim 1,wherein each layer of the reversibly responsive expandable devicehousing including multiple layers of biodegradable material isresponsive to degradative chemicals.
 3. The device of claim 1, furtherincluding a protease.
 4. The device of claim 1, wherein degradation ofone or more layers of the reversibly responsive expandable devicehousing including multiple layers of biodegradable material ispredetermined or customized to a particular subject.
 5. The device ofclaim 1, wherein degradation of one or more layers of the reversiblyresponsive expandable device housing including multiple layers ofbiodegradable material is directed by at least one of a sensor orwireless controller.
 6. The device of claim 1, wherein the one or moreglucose-responsive, pH-sensitive hydrogels are equally dispersed betweenlayers of the biodegradable material.
 7. The device of claim 1, whereinthe reversibly responsive expandable device housing includes a polymerformed by a three dimensional model.
 8. The device of claim 7, whereinthe three dimensional model includes a computer generated model.
 9. Thedevice of claim 7, wherein the reversibly responsive expandable devicehousing is formed using a three dimensional printer.
 10. The device ofclaim 1, wherein the reversibly responsive expandable device housing isoperably coupled to the at least one port.
 11. The device of claim 1,wherein the reversibly responsive expandable device housing is passivelyexpandable based on the glucose or pH condition in the stomach of thesubject.
 12. The device of claim 1, wherein the reversibly responsiveexpandable device housing is controllably expandable based on asubstance ingested by the subject.
 13. The device of claim 1, whereinthe one or more glucose-responsive, pH-sensitive hydrogels a finitelifespan.
 14. The device of claim 1, wherein the one or moreglucose-responsive, pH-sensitive hydrogels can be re-used severalfeeding cycles of the subject.
 15. The device of claim 1, wherein theone or more glucose-responsive, pH-sensitive hydrogels can be used foronly one feeding cycle of the subject.
 16. The device of claim 1,wherein the reversibly responsive expandable device housing is encasedby a container.
 17. The device of claim 16, wherein the containerincludes a reversibly responsive expandable mesh.
 18. The device ofclaim 1, further including at least one chemical sensor operably coupledto the port.
 19. The device of claim 18, wherein the at least onechemical sensor is configured to detect at least one chemical present inthe subject.
 20. The device of claim 18, wherein the at least one portincludes at least one intelligent responsive matrix.
 21. The device ofclaim 1, further including at least one hunger control deliveryreservoir including at least one fluid for activating the one or moreglucose-responsive, pH-sensitive hydrogels.
 22. The device of claim 21,wherein the at least one fluid for activating the one or moreglucose-responsive, pH-sensitive hydrogels include acidified water. 23.The device of claim 1, further including at least one controllablemicropump or controllable valve operably connected to control circuitry.24. The device of claim 23, wherein the control circuitry includeswireless control of the at least one controllable micropump orcontrollable valve.
 25. The device of claim 23, wherein the at least onecontrollable micropump or controllable valve is operably connected to atleast one transmitter.
 26. The device of claim 23, wherein the at leastone controllable micropump or controllable valve is operably connectedto at least one receiver.
 27. The device of claim 23, wherein the atleast one controllable micropump or controllable valve is operablyconnected to at least one energy storage device.
 28. The device of claim27, wherein the energy storage device includes a battery.
 29. The deviceof claim 28, wherein the battery includes at least one of amicrobattery, thin film battery, or rechargeable battery.
 30. The deviceof claim 1, wherein the hydrogel is formulated for gradual release ofthe at least one appetite suppressant from the one or moreglucose-responsive, pH-sensitive hydrogels.
 31. The device of claim 1,wherein the one or more glucose-responsive, pH-sensitive hydrogels areformulated to release at least one appetite suppressant by way ofdiffusion or dissolution of the one or more glucose-responsive,pH-sensitive hydrogels.
 32. The device of claim 1, wherein the hydrogelis coated in the at least one appetite suppressant.
 33. The device ofclaim 1, further including at least two different responsive matrices,wherein at least one responsive matrix undergoes expansion and at leastone different responsive matrix undergoes contraction responsive to thesame stimulus.
 34. The device of claim 1, wherein the reversiblyresponsive expandable device housing is sized for eventual passagethrough the gastrointestinal tract of the subject.
 35. The device ofclaim 1, further including at least one controllable micropump orcontrollable valve configured to control the flow of fluid into thereversibly responsive expandable device housing.
 36. The device of claim1, wherein the reversibly responsive expandable device housing is sizedfor oral administration to the subject.
 37. The device of claim 1,wherein the reversibly responsive expandable device housing includes oneor more energy storage devices.
 38. The device of claim 1, wherein thereversibly responsive expandable device housing includes one or more ofa ratchet member, threaded member, or lever member.
 39. The device ofclaim 1, wherein the reversibly responsive expandable device housing isat least one of biodegradable or biocompatible.
 40. The device of claim1, wherein the reversibly responsive expandable device housing includeschitosan on at least one external interface.
 41. A method of hungercontrol in a subject, comprising: activating a stomach-volume-reducingdevice located in a subject's stomach, the stomach-volume-reducingdevice including a reversibly responsive expandable device housingwherein the reversibly responsive expandable device housing isconfigured to reversibly expand or contract and includes multiple layersof glucose-responsive, pH-sensitive hydrogel containing at least oneappetite suppressant, and at least one port.
 42. A system, comprising:circuitry configured to operate at least one stomach-volume-reducingdevice with a reversibly responsive expandable device housing configuredto reversibly expand or contract and that includes multiple layers ofglucose-responsive, pH-sensitive hydrogel containing at least oneappetite suppressant, and at least one port.